Trial Outcomes & Findings for A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood (NCT NCT05613777)
NCT ID: NCT05613777
Last Updated: 2026-05-06
Results Overview
This outcome measured the area under the concentration-time curve of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
Results posted on
2026-05-06
Participant Flow
This was a non-randomised, open-label, 2-period, fixed sequence trial with a run-in period and without a wash-out period between the treatments to test whether Iclepertin (BI 425809) influences the amount of a contraceptive (Microgynon®) in the blood. Participants underwent a run-in period of at least 28 days before the Period 1 of the trial to exclude any possible interactions with preceding oral contraceptive regime (OC) and to minimize the influence of adaptation to a newly administered OC.
All participants were screened for eligibility prior to participation in the trial. Participants were not to be allocated to a treatment group if any of the entry criteria were violated. Nineteen participants enrolled in the trial but only 17 were treated according to the clinical trial protocol: one participant was not treated due to an adverse event (AE) prior to the run-in period, and one other participant was treated with OC but did not start Period 1 and 2 due to an AE.
Participant milestones
| Measure |
Microgynon® (R), Then Microgynon® + Iclepertin (T)
Participants received two treatments in the following order:
Period 1 - Microgynon® (R): Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings of days 1 to 21, followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water after an overnight fast of at least 10 hours on day 1, and day 18 to 21. On days 2 to 17 fasting was not mandatory.
Period 2 - Microgynon® + Iclepertin (T): Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) and one 10 milligram film-coated tablet of Iclepertin (BI 425809) in the mornings of day 1 to 21, followed by 7 days where no treatment was administered. Iclepertin and Microgynon® were administered orally with 240 millilitres of water after an overnight fast of at least 10 hours.
There was no wash-out period between Period 1 and Period 2.
|
|---|---|
|
Period 1 - Microgynon® (R)
STARTED
|
17
|
|
Period 1 - Microgynon® (R)
COMPLETED
|
17
|
|
Period 1 - Microgynon® (R)
NOT COMPLETED
|
0
|
|
Period 2 - Microgynon® + Iclepertin (T)
STARTED
|
17
|
|
Period 2 - Microgynon® + Iclepertin (T)
COMPLETED
|
14
|
|
Period 2 - Microgynon® + Iclepertin (T)
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Microgynon® (R), Then Microgynon® + Iclepertin (T)
Participants received two treatments in the following order:
Period 1 - Microgynon® (R): Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings of days 1 to 21, followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water after an overnight fast of at least 10 hours on day 1, and day 18 to 21. On days 2 to 17 fasting was not mandatory.
Period 2 - Microgynon® + Iclepertin (T): Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) and one 10 milligram film-coated tablet of Iclepertin (BI 425809) in the mornings of day 1 to 21, followed by 7 days where no treatment was administered. Iclepertin and Microgynon® were administered orally with 240 millilitres of water after an overnight fast of at least 10 hours.
There was no wash-out period between Period 1 and Period 2.
|
|---|---|
|
Period 2 - Microgynon® + Iclepertin (T)
Withdrawal by Subject
|
2
|
|
Period 2 - Microgynon® + Iclepertin (T)
Adverse Event
|
1
|
Baseline Characteristics
A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood
Baseline characteristics by cohort
| Measure |
Microgynon® (R), Then Microgynon® + Iclepertin (T)
n=17 Participants
Participants received two treatments in the following order:
Period 1 - Microgynon® (R): Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings of days 1 to 21, followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water after an overnight fast of at least 10 hours on day 1, and day 18 to 21. On days 2 to 17 fasting was not mandatory.
Period 2 - Microgynon® + Iclepertin (T): Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) and one 10 milligram film-coated tablet of Iclepertin (BI 425809) in the mornings of day 1 to 21, followed by 7 days where no treatment was administered. Iclepertin and Microgynon® were administered orally with 240 millilitres of water after an overnight fast of at least 10 hours.
There was no wash-out period between Period 1 and Period 2.
|
|---|---|
|
Age, Continuous
|
27.1 Years
STANDARD_DEVIATION 5.2 • n=54 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.Population: Pharmacokinetic (PK) parameter analysis set: all subjects who were treated with at least one dose of trial drug during the trial treatment periods (Period 1 and Period 2) and who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
This outcome measured the area under the concentration-time curve of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Outcome measures
| Measure |
Microgynon® (R)
n=17 Participants
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings of days 1 to 21, followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water after an overnight fast of at least 10 hours on day 1, and day 18 to 21. On days 2 to 17 fasting was not mandatory.
|
Microgynon® + Iclepertin (T)
n=14 Participants
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) and one 10 milligram film-coated tablet of Iclepertin (BI 425809) in the mornings of day 1 to 21, followed by 7 days where no treatment was administered. Iclepertin and Microgynon® were administered orally with 240 millilitres of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
|
916.63 hour*picogram/milliliter
Standard Error NA
Adjusted geometric standard error = 1.07
|
942.17 hour*picogram/milliliter
Standard Error NA
Adjusted geometric standard error = 1.07
|
PRIMARY outcome
Timeframe: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.Population: Pharmacokinetic (PK) parameter analysis set: all subjects who were treated with at least one dose of trial drug during the trial treatment periods (Period 1 and Period 2) and who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
This outcome measured the area under the concentration-time curve of levonogestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Outcome measures
| Measure |
Microgynon® (R)
n=17 Participants
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings of days 1 to 21, followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water after an overnight fast of at least 10 hours on day 1, and day 18 to 21. On days 2 to 17 fasting was not mandatory.
|
Microgynon® + Iclepertin (T)
n=14 Participants
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) and one 10 milligram film-coated tablet of Iclepertin (BI 425809) in the mornings of day 1 to 21, followed by 7 days where no treatment was administered. Iclepertin and Microgynon® were administered orally with 240 millilitres of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Levonogestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
|
102541.7 hour*picogram/milliliter
Standard Error NA
Adjusted geometric standard error = 1.07
|
106443.0 hour*picogram/milliliter
Standard Error NA
Adjusted geometric standard error = 1.07
|
PRIMARY outcome
Timeframe: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.Population: Pharmacokinetic (PK) parameter analysis set: all subjects who were treated with at least one dose of trial drug during the trial treatment periods (Period 1 and Period 2) and who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
This outcome measured the maximum measured concentration of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Outcome measures
| Measure |
Microgynon® (R)
n=17 Participants
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings of days 1 to 21, followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water after an overnight fast of at least 10 hours on day 1, and day 18 to 21. On days 2 to 17 fasting was not mandatory.
|
Microgynon® + Iclepertin (T)
n=14 Participants
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) and one 10 milligram film-coated tablet of Iclepertin (BI 425809) in the mornings of day 1 to 21, followed by 7 days where no treatment was administered. Iclepertin and Microgynon® were administered orally with 240 millilitres of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Maximum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
|
91.44 picogram/milliliter
Standard Error NA
Adjusted geometric standard error = 1.07
|
94.32 picogram/milliliter
Standard Error NA
Adjusted geometric standard error = 1.08
|
PRIMARY outcome
Timeframe: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.Population: Pharmacokinetic (PK) parameter analysis set: all subjects who were treated with at least one dose of trial drug during the trial treatment periods (Period 1 and Period 2) and who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
This outcome measured the maximum measured concentration of levonorgestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Outcome measures
| Measure |
Microgynon® (R)
n=17 Participants
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings of days 1 to 21, followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water after an overnight fast of at least 10 hours on day 1, and day 18 to 21. On days 2 to 17 fasting was not mandatory.
|
Microgynon® + Iclepertin (T)
n=14 Participants
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) and one 10 milligram film-coated tablet of Iclepertin (BI 425809) in the mornings of day 1 to 21, followed by 7 days where no treatment was administered. Iclepertin and Microgynon® were administered orally with 240 millilitres of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Maximum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
|
8841.40 picogram/milliliter
Standard Error NA
Adjusted geometric standard error = 1.06
|
9388.81 picogram/milliliter
Standard Error NA
Adjusted geometric standard error = 1.06
|
PRIMARY outcome
Timeframe: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.Population: Pharmacokinetic (PK) parameter analysis set: all subjects who were treated with at least one dose of trial drug during the trial treatment periods (Period 1 and Period 2) and who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
This outcome measured the minimum measured concentration of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Outcome measures
| Measure |
Microgynon® (R)
n=17 Participants
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings of days 1 to 21, followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water after an overnight fast of at least 10 hours on day 1, and day 18 to 21. On days 2 to 17 fasting was not mandatory.
|
Microgynon® + Iclepertin (T)
n=14 Participants
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) and one 10 milligram film-coated tablet of Iclepertin (BI 425809) in the mornings of day 1 to 21, followed by 7 days where no treatment was administered. Iclepertin and Microgynon® were administered orally with 240 millilitres of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Minimum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss )
|
16.60 picogram/milliliter
Standard Error NA
Adjusted geometric standard error = 1.09
|
17.10 picogram/milliliter
Standard Error NA
Adjusted geometric standard error = 1.10
|
PRIMARY outcome
Timeframe: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.Population: Pharmacokinetic (PK) parameter analysis set: all subjects who were treated with at least one dose of trial drug during the trial treatment periods (Period 1 and Period 2) and who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
This outcome measured the minimum measured concentration of Levonorgestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Outcome measures
| Measure |
Microgynon® (R)
n=17 Participants
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings of days 1 to 21, followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water after an overnight fast of at least 10 hours on day 1, and day 18 to 21. On days 2 to 17 fasting was not mandatory.
|
Microgynon® + Iclepertin (T)
n=14 Participants
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) and one 10 milligram film-coated tablet of Iclepertin (BI 425809) in the mornings of day 1 to 21, followed by 7 days where no treatment was administered. Iclepertin and Microgynon® were administered orally with 240 millilitres of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Minimum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss )
|
2799.32 picogram/milliliter
Standard Error NA
Adjusted geometric standard error = 1.09
|
2845.24 picogram/milliliter
Standard Error NA
Adjusted geometric standard error = 1.09
|
Adverse Events
Microgynon® (Run-in)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Microgynon® (R)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Microgynon® + Iclepertin (T)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Microgynon® (Run-in)
n=18 participants at risk
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings for 21-49 days (depending on duration of menstrual cycle), followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water.
|
Microgynon® (R)
n=17 participants at risk
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings of days 1 to 21, followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water after an overnight fast of at least 10 hours on day 1, and day 18 to 21. On days 2 to 17 fasting was not mandatory.
|
Microgynon® + Iclepertin (T)
n=17 participants at risk
Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) and one 10 milligram film-coated tablet of Iclepertin (BI 425809) in the mornings of day 1 to 21, followed by 7 days where no treatment was administered. Iclepertin and Microgynon® were administered orally with 240 millilitres of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Eye disorders
Photophobia
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
17.6%
3/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
General disorders
Fatigue
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
11.8%
2/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
General disorders
Peripheral swelling
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
17.6%
3/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
11.8%
2/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
17.6%
3/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
17.6%
3/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
29.4%
5/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Nervous system disorders
Syncope
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
11.1%
2/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
5.9%
1/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
11.1%
2/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Gastrointestinal disorders
Toothache
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
General disorders
Face oedema
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
General disorders
Localised oedema
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Infections and infestations
Gastroenteritis
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Investigations
Weight increased
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Psychiatric disorders
Mood altered
|
11.1%
2/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.6%
1/18 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
0.00%
0/17 • Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study. Time frame (continued): Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER