Trial Outcomes & Findings for Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women (NCT NCT03228680)
NCT ID: NCT03228680
Last Updated: 2023-08-24
Results Overview
The number of oocytes retrieved was recorded at the oocyte retrieval visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
373 participants
Primary outcome timeframe
36h (± 2h) after triggering of final follicular maturation (On day of oocyte retrieval)
Results posted on
2023-08-24
Participant Flow
A total of 17 investigational sites in Japan randomized participants to the trial between 29 July 2017 to 08 July 2019.
A total of 373 participants were screened. Of these, 25 were screening failures and 348 participants were randomized: 170 participants were exposed to FE 999049 \& 177 participants were exposed to FOLLISTIM. One participant was randomized to FOLLISTIM but not exposed to investigational medicinal product (IMP) was considered a randomization failure.
Participant milestones
| Measure |
FE 999049 (Follitropin Delta)
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FOLLISTIM (Follitropin Beta)
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Overall Study
STARTED
|
170
|
178
|
|
Overall Study
COMPLETED
|
147
|
143
|
|
Overall Study
NOT COMPLETED
|
23
|
35
|
Reasons for withdrawal
| Measure |
FE 999049 (Follitropin Delta)
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FOLLISTIM (Follitropin Beta)
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
18
|
|
Overall Study
Randomization failure
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Other
|
9
|
16
|
Baseline Characteristics
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women
Baseline characteristics by cohort
| Measure |
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
Total
n=347 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.2 years
STANDARD_DEVIATION 3.5 • n=99 Participants
|
34.0 years
STANDARD_DEVIATION 3.4 • n=107 Participants
|
34.1 years
STANDARD_DEVIATION 3.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
170 Participants
n=99 Participants
|
177 Participants
n=107 Participants
|
347 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
170 Participants
n=99 Participants
|
177 Participants
n=107 Participants
|
347 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
170 Participants
n=99 Participants
|
177 Participants
n=107 Participants
|
347 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
170 participants
n=99 Participants
|
177 participants
n=107 Participants
|
347 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 36h (± 2h) after triggering of final follicular maturation (On day of oocyte retrieval)Population: The full analysis set (FAS) comprised all randomized and exposed participants.
The number of oocytes retrieved was recorded at the oocyte retrieval visit.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Number of Oocytes Retrieved
|
10.5 Oocytes retrieved
Standard Deviation 6.1
|
9.3 Oocytes retrieved
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 5-6 weeks after transfer (up to approximately 3 months after start of stimulation)Population: The FAS comprised of all randomized and exposed participants.
Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Clinical Pregnancy Rate
|
23.7 percentage of participants
|
25.3 percentage of participants
|
SECONDARY outcome
Timeframe: 13-15 days after transfer (up to approximately 1.5 months after start of stimulation)Population: The FAS comprised of all randomized and exposed participants.
Defined as positive serum beta-hCG test 13-15 days after transfer.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Positive Beta Unit of Human Chorionic Gonadotropin (Beta-hCG) Rate
|
29.4 percentage of participants
|
29.4 percentage of participants
|
SECONDARY outcome
Timeframe: 5-6 weeks after transfer (up to approximately 3 months after start of stimulation)Population: The FAS comprised of all randomized and exposed participants.
Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Vital Pregnancy Rate
|
21.5 percentage of participants
|
23.5 percentage of participants
|
SECONDARY outcome
Timeframe: 5-6 weeks after transfer (up to approximately 3 months after start of stimulation)Population: The FAS comprised of all randomized and exposed participants with blastocyst transfer.
Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by the number of blastocysts transferred.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=141 Embryos transferred
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=135 Embryos transferred
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Implantation Rate
|
29.8 % of sacs/blastocysts transferred
|
31.9 % of sacs/blastocysts transferred
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The FAS comprised of all randomized and exposed participants.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Proportion of Participants With Cycle Cancellation Due to Poor or Excessive Ovarian Response
Cycle cancelled due to poor ovarian response
|
0.6 percentage of participants
|
1.2 percentage of participants
|
|
Proportion of Participants With Cycle Cancellation Due to Poor or Excessive Ovarian Response
Cycle cancelled due to excessive ovarian response
|
1.1 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The FAS comprised of all randomized and exposed participants.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Proportion of Participants With Blastocyst Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk
|
11.3 percentage of participants
|
7.6 percentage of participants
|
SECONDARY outcome
Timeframe: On the day of oocyte retrieval (up to 22 days after start of stimulation)Population: The FAS comprised of all randomized and exposed participants.
Defined as proportion of participants grouped according to the number of oocytes retrieved. The proportion of participants with \<4 oocytes (low response), 4-7 oocytes (moderate response), 8-14 oocytes (targeted response), 15-19 oocytes (hyperresponse) and ≥20 oocytes (severe hyperresponse) are presented.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=173 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=169 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Proportion of Participants With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
Low response (<4 oocytes)
|
5.2 percentage of participants
|
8.3 percentage of participants
|
|
Proportion of Participants With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
Moderate response (4-7 oocytes)
|
26.6 percentage of participants
|
36.1 percentage of participants
|
|
Proportion of Participants With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
Targeted response (8-14 oocytes)
|
42.8 percentage of participants
|
40.8 percentage of participants
|
|
Proportion of Participants With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
Hyperresponse (15-19 oocytes)
|
14.5 percentage of participants
|
10.1 percentage of participants
|
|
Proportion of Participants With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
Severe hyperresponse (≥ 20 oocytes)
|
11.0 percentage of participants
|
4.7 percentage of participants
|
SECONDARY outcome
Timeframe: On the day of oocyte retrieval (up to 22 days after start of stimulation)Population: The FAS comprised of all randomized and exposed participants.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=173 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=169 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Proportion of Participants With Extreme Ovarian Responses (Defined as <4, ≥15 or ≥20 Oocytes Retrieved) in Risk Population
AMH < 15 pmol/L (<4 oocytes retrieved)
|
12.3 percentage of participants
|
11.6 percentage of participants
|
|
Proportion of Participants With Extreme Ovarian Responses (Defined as <4, ≥15 or ≥20 Oocytes Retrieved) in Risk Population
AMH >= 15 pmol/L (>=15 oocytes retrieved)
|
42.0 percentage of participants
|
22.0 percentage of participants
|
|
Proportion of Participants With Extreme Ovarian Responses (Defined as <4, ≥15 or ≥20 Oocytes Retrieved) in Risk Population
AMH >= 15 pmol/L (>=20 oocytes retrieved)
|
19.0 percentage of participants
|
8.0 percentage of participants
|
SECONDARY outcome
Timeframe: ≤9 days after triggering of final follicular maturationPopulation: The FAS comprised of all participants randomized or exposed.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Proportion of Participants With Preventive Interventions for Early Ovarian Hyperstimulation Syndrome (OHSS)
Cycle cancellation
|
1.1 percentage of participants
|
0 percentage of participants
|
|
Proportion of Participants With Preventive Interventions for Early Ovarian Hyperstimulation Syndrome (OHSS)
Triggering with GnRH agonist
|
1.1 percentage of participants
|
1.2 percentage of participants
|
|
Proportion of Participants With Preventive Interventions for Early Ovarian Hyperstimulation Syndrome (OHSS)
Administration of dopamine agonist
|
1.7 percentage of participants
|
0.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 9 days after triggering of final follicular maturationPopulation: The FAS comprised of all participants randomized and exposed.
Defined as proportion of participants with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Proportions of Participants With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS
Early OHSS (any grade)
|
18.6 percentage of participants
|
10.0 percentage of participants
|
|
Proportions of Participants With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS
Early OHSS (moderate/severe)
|
13.0 percentage of participants
|
6.5 percentage of participants
|
|
Proportions of Participants With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS
Early OHSS (any grade) and/or preventive
|
20.9 percentage of participants
|
10.6 percentage of participants
|
|
Proportions of Participants With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS
Early OHSS (moderate/severe) and/or preventive
|
16.4 percentage of participants
|
7.6 percentage of participants
|
SECONDARY outcome
Timeframe: >9 days after triggering of final follicular maturationPopulation: The FAS comprised of all participants randomized or exposed.
Defined as proportions of participants with late OHSS (including OHSS of moderate/severe grade). Late OHSS was defined as OHSS with onset \>9 days after triggering of final follicular maturation. The proportion of participants with late OHSS, and late OHSS of moderate or severe grade are presented. All OHSS cases were graded as mild, moderate, or severe.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Proportions of Participants With Late OHSS (Including OHSS of Moderate/Severe Grade)
Late OHSS (any grade)
|
1.1 percentage of participants
|
1.2 percentage of participants
|
|
Proportions of Participants With Late OHSS (Including OHSS of Moderate/Severe Grade)
Late OHSS (moderate/severe)
|
1.1 percentage of participants
|
0.6 percentage of participants
|
SECONDARY outcome
Timeframe: At Day 6 of stimulationPopulation: The FAS comprised of all randomized or exposed participants.
Defined as the number of follicles observed in both ovaries at the last transvaginal ultrasound (TVUS) in the stimulation phase (on stimulation Day 6).
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Number of Follicles on Stimulation Day 6
|
13.3 Follicles
Standard Deviation 7.1
|
12.8 Follicles
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The FAS comprised of all randomized or exposed participants.
Defined as the number of follicles observed in both ovaries at the last TVUS in the stimulation phase (end-of-stimulation).
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Number of Follicles at End-of-stimulation
|
16.3 Follicles
Standard Deviation 8.8
|
14.9 Follicles
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: At Day 6 of stimulationPopulation: The FAS comprised of all randomized and exposed participants
Defined as size characteristics of follicles on stimulation Day 6. Average size of 3 largest follicles has been presented in this endpoint.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Size of Follicles on Stimulation Day 6
|
12.8 mm
Standard Deviation 2.0
|
12.7 mm
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The FAS comprised of all randomized and exposed participants
Defined as size characteristics of follicles at end-of-stimulation. Average size of 3 largest follicles has been presented in this endpoint.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Size of Follicles at End-of-Stimulation
|
19.4 mm
Standard Deviation 1.6
|
19.2 mm
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Day 1 after oocyte retrieval (up to approximately 22 days after start of stimulation)Population: The FAS comprised all randomized and exposed participants
The fertilization rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Fertilization Rate
|
57.1 percentage of fertilized oocytes
Standard Deviation 23.4
|
54.5 percentage of fertilized oocytes
Standard Deviation 26.1
|
SECONDARY outcome
Timeframe: Day 3 after oocyte retrieval (up to approximately 24 days after start of stimulation)Population: The FAS comprised of all randomized and exposed participants.
Number of embryos (total and good-quality) on Day 3 are presented. A good-quality embryo was defined as an embryo with ≥6 blastomeres and fragmentation ≤20% on Day 3.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Number and Quality of Embryos
Number of embryo
|
7.0 Embryo
Standard Deviation 4.3
|
5.8 Embryo
Standard Deviation 4.2
|
|
Number and Quality of Embryos
Number of good-quality embryo
|
4.6 Embryo
Standard Deviation 3.3
|
3.9 Embryo
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Day 5 after oocyte retrieval (up to approximately 26 days after start of stimulation)Population: The FAS comprised of all randomized and exposed participants.
Number of embryos (total and good-quality) on Day 5 are presented. The quality evaluation of blastocysts consisted of assessment of three parameters, as per the Gardner \& Schoolcraft system: blastocyst expansion and hatching status (graded: 1-6), inner cell mass (graded: A-D) and trophectoderm (graded: A-D). A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Number and Quality of Blastocysts
Number of blastocysts
|
4.2 Blastocysts
Standard Deviation 3.4
|
3.1 Blastocysts
Standard Deviation 2.7
|
|
Number and Quality of Blastocysts
Number of good-quality blastocysts
|
3.0 Blastocysts
Standard Deviation 2.6
|
2.3 Blastocysts
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: At Day 6 of stimulationPopulation: The FAS comprised of all randomized and exposed participants.
The median and inter-quartile range (IQR) of FSH and LH levels on stimulation Day 6 are presented.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=175 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=166 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) on Stimulation Day 6
FSH
|
14.7 IU/L
Interval 12.8 to 17.3
|
15.4 IU/L
Interval 12.0 to 19.6
|
|
Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) on Stimulation Day 6
LH
|
2.8 IU/L
Interval 1.6 to 5.9
|
2.6 IU/L
Interval 1.5 to 6.2
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The FAS comprised of all randomized and exposed participants.
The median and IQR of FSH and LH levels at end-of-stimulation are presented.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=172 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=169 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) at End-of-stimulation
FSH
|
16.4 IU/L
Interval 13.5 to 20.4
|
14.3 IU/L
Interval 11.6 to 19.7
|
|
Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) at End-of-stimulation
LH
|
1.4 IU/L
Interval 0.9 to 2.3
|
1.6 IU/L
Interval 1.0 to 2.5
|
SECONDARY outcome
Timeframe: At Day 6 of stimulationPopulation: The FAS comprised of all randomized and exposed participants.
The median and IQR of estradiol levels on stimulation Day 6 are presented.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=175 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=166 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Circulating Levels of Endocrine Parameter (Estradiol) on Stimulation Day 6
|
2680.0 pmol/L
Interval 1608.8 to 4685.9
|
2277.1 pmol/L
Interval 1479.4 to 3580.1
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The FAS comprised of all randomized and exposed participants.
The median and IQR of estradiol levels at end-of-stimulation are presented.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=172 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=169 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Circulating Levels of Endocrine Parameter (Estradiol) at End-of-stimulation
|
7438.8 pmol/L
Interval 5363.6 to 10283.1
|
6517.0 pmol/L
Interval 4465.3 to 9033.4
|
SECONDARY outcome
Timeframe: At Day 6 of stimulationPopulation: The FAS comprised of all randomized and exposed participants.
The median and IQR of progesterone levels on stimulation Day 6 are presented.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=175 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=166 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Circulating Levels of Endocrine Parameter (Progesterone) on Stimulation Day 6
|
1.7 nmol/L
Interval 0.8 to 2.65
|
1.7 nmol/L
Interval 0.8 to 2.4
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The FAS comprised of all randomized and exposed participants.
The median and IQR of progesterone levels at end-of-stimulation are presented.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=172 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=168 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Circulating Levels of Endocrine Parameter (Progesterone) at End-of-stimulation
|
3.1 nmol/L
Interval 2.3 to 4.3
|
2.5 nmol/L
Interval 1.9 to 3.5
|
SECONDARY outcome
Timeframe: At Day 6 of stimulationPopulation: The FAS comprised of all randomized and exposed participants.
The median and IQR of Inhibin A levels on stimulation Day 6 are presented.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=175 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=166 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Circulating Levels of Endocrine Parameters (Inhibin A) on Stimulation Day 6
|
129.8 ng/L
Interval 81.6 to 210.6
|
113.1 ng/L
Interval 75.1 to 171.9
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The FAS comprised of all randomized and exposed participants.
The median and IQR of Inhibin A levels at end-of-stimulation are presented.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=172 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=169 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Circulating Levels of Endocrine Parameters (Inhibin A) at End-of-stimulation
|
390.3 ng/L
Interval 301.0 to 551.1
|
323.8 ng/L
Interval 222.1 to 458.8
|
SECONDARY outcome
Timeframe: At Day 6 of stimulationPopulation: The FAS comprised of all randomized and exposed participants.
The median and IQR of inhibin B levels on stimulation Day 6 are presented.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=175 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=166 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Circulating Levels of Endocrine Parameters (Inhibin B) on Stimulation Day 6
|
686.0 ng/L
Interval 431.0 to 1004.0
|
570.5 ng/L
Interval 396.0 to 853.0
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The FAS comprised of all randomized and exposed participants.
The median and IQR of inhibin B levels at end-of-stimulation are presented.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=172 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=169 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Circulating Levels of Endocrine Parameters (Inhibin B) at End-of-stimulation
|
734.5 ng/L
Interval 492.5 to 1120.5
|
686.0 ng/L
Interval 461.0 to 1057.0
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The safety analysis set comprised of all randomized and exposed participants.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Number of Stimulation Days
|
8.8 Days
Standard Deviation 1.7
|
8.9 Days
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The safety analysis set comprised of all randomized and exposed participants.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Total Gonadotropin Dose of FE 999049
|
—
|
83.5 μg
Standard Deviation 28.9
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The safety analysis set comprised of all randomized and exposed participants.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=177 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Total Gonadotropin Dose of FOLLISTIM
|
—
|
1499 IU
Standard Deviation 514
|
SECONDARY outcome
Timeframe: From signed informed consent up to 5-6 weeks after transferPopulation: The safety analysis set comprised of all randomized and exposed participants.
The frequency of participants with total AEs and AEs by categories of intensity (mild, moderate, severe) are presented. An AE was any untoward medical occurrence in a participants participating in clinical trial. The intensity of AE was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity); moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) Stratified by Intensity
Any AE
|
92 Participants
|
73 Participants
|
|
Number of Participants With Adverse Events (AEs) Stratified by Intensity
Mild AE
|
86 Participants
|
69 Participants
|
|
Number of Participants With Adverse Events (AEs) Stratified by Intensity
Moderate AE
|
12 Participants
|
8 Participants
|
|
Number of Participants With Adverse Events (AEs) Stratified by Intensity
Severe AE
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The safety analysis set comprised of all randomized and exposed participants.
Defined as number of participants with at least one markedly abnormal finding in clinical chemistry parameters (as assessed by investigator) were reported. The clinical chemistry parameters included: alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, bilirubin direct, bilirubin total, blood urea nitrogen, calcium, chloride, cholesterol total, creatinine, gamma-glutamyl transpeptidase, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, uric acid.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-stimulation
ALT (IU/L): Normal to markedly high (>3xULN)
|
1 participants
|
0 participants
|
|
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-stimulation
AST (IU/L): Normal to markedly high (>3xULN)
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The safety analysis set comprised of all randomized and exposed participants.
Defined as number of participants with at least one markedly abnormal changes in hematology parameters (as assessed by investigator) were reported. Hematology parameters included: red blood cells, white blood cells, red blood cells morphology, white blood cells morphology, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, platelets.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-stimulation
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 5-6 weeks after transferPopulation: The safety analysis set comprised of all randomized and exposed participants.
Defined as number of participants with at least one markedly abnormal finding in clinical chemistry parameters (as assessed by investigator) were reported. The clinical chemistry parameters included: alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, bilirubin direct, bilirubin total, blood urea nitrogen, calcium, chloride, cholesterol total, creatinine, gamma-glutamyl transpeptidase, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, uric acid.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-trial
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 5-6 weeks after transferPopulation: The safety analysis set comprised of all randomized and exposed participants.
Defined as number of participants with at least one markedly abnormal changes in hematology parameters (as assessed by investigator) were reported. Hematology parameters included: red blood cells, white blood cells, red blood cells morphology, white blood cells morphology, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, platelets.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-trial
Leukocytes (10^9/L) Normal to markedly high (>=16)
|
1 participants
|
0 participants
|
|
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-trial
Hemoglobin (g/L) Normal to markedly low
|
1 participants
|
0 participants
|
|
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-trial
Hematocrit (ratio) Normal to markedly low (>=0.56)
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The safety analysis set comprised of all randomized and exposed participants.
The presence of of injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after the injection are presented. The injection site reactions were assessed as none, mild, moderate and severe. The number of injection site reactions (mild, moderate or severe) based on all assessments performed is presented.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Frequency and Intensity of Injection Site Reactions
Severe swelling
|
0 events
|
0 events
|
|
Frequency and Intensity of Injection Site Reactions
Any mild injection site reaction
|
719 events
|
271 events
|
|
Frequency and Intensity of Injection Site Reactions
Any moderate injection site reaction
|
19 events
|
7 events
|
|
Frequency and Intensity of Injection Site Reactions
Any severe injection site reaction
|
0 events
|
1 events
|
|
Frequency and Intensity of Injection Site Reactions
Mild redness
|
174 events
|
140 events
|
|
Frequency and Intensity of Injection Site Reactions
Moderate redness
|
0 events
|
2 events
|
|
Frequency and Intensity of Injection Site Reactions
Severe redness
|
0 events
|
0 events
|
|
Frequency and Intensity of Injection Site Reactions
Mild itching
|
5 events
|
4 events
|
|
Frequency and Intensity of Injection Site Reactions
Moderate itching
|
0 events
|
1 events
|
|
Frequency and Intensity of Injection Site Reactions
Severe itching
|
0 events
|
0 events
|
|
Frequency and Intensity of Injection Site Reactions
Mild pain
|
411 events
|
19 events
|
|
Frequency and Intensity of Injection Site Reactions
Moderate pain
|
16 events
|
1 events
|
|
Frequency and Intensity of Injection Site Reactions
Severe pain
|
0 events
|
0 events
|
|
Frequency and Intensity of Injection Site Reactions
Mild swelling
|
10 events
|
6 events
|
|
Frequency and Intensity of Injection Site Reactions
Moderate swelling
|
0 events
|
0 events
|
|
Frequency and Intensity of Injection Site Reactions
Mild bruising
|
119 events
|
102 events
|
|
Frequency and Intensity of Injection Site Reactions
Moderate bruising
|
3 events
|
3 events
|
|
Frequency and Intensity of Injection Site Reactions
Severe bruising
|
0 events
|
1 events
|
SECONDARY outcome
Timeframe: End-of-stimulation (up to 20 stimulation days)Population: The safety analysis set comprised of all randomized and exposed participants.
Outcome measures
| Measure |
FOLLISTIM (Follitropin Beta)
n=177 Participants
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FE 999049 (Follitropin Delta)
n=170 Participants
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Technical Malfunctions of the Administration Pens
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
FE 999049 (Follitropin Delta)
Serious events: 0 serious events
Other events: 73 other events
Deaths: 0 deaths
FOLLISTIM (Follitropin Beta)
Serious events: 2 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FE 999049 (Follitropin Delta)
n=170 participants at risk
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FOLLISTIM (Follitropin Beta)
n=177 participants at risk
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
0.00%
0/170 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
1.1%
2/177 • Number of events 2 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
Other adverse events
| Measure |
FE 999049 (Follitropin Delta)
n=170 participants at risk
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
FOLLISTIM (Follitropin Beta)
n=177 participants at risk
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.4%
4/170 • Number of events 4 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
2.8%
5/177 • Number of events 6 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
|
General disorders
Injection site erythema
|
7.6%
13/170 • Number of events 14 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
8.5%
15/177 • Number of events 15 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
|
General disorders
Injection site pruritus
|
0.00%
0/170 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
2.8%
5/177 • Number of events 5 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.5%
6/170 • Number of events 6 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
3.4%
6/177 • Number of events 6 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
|
Nervous system disorders
Headache
|
2.4%
4/170 • Number of events 4 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
2.3%
4/177 • Number of events 4 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
|
Pregnancy, puerperium and perinatal conditions
Biochemical pregnancy
|
3.5%
6/170 • Number of events 6 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
5.6%
10/177 • Number of events 10 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontenous
|
1.8%
3/170 • Number of events 3 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
2.3%
4/177 • Number of events 4 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
|
2.4%
4/170 • Number of events 4 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
0.00%
0/177 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
11.2%
19/170 • Number of events 19 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
19.8%
35/177 • Number of events 35 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
2.9%
5/170 • Number of events 5 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
4.0%
7/177 • Number of events 7 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
|
Reproductive system and breast disorders
Ovarian enlargement
|
2.9%
5/170 • Number of events 5 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
2.8%
5/177 • Number of events 5 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
2.4%
4/170 • Number of events 4 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
2.3%
4/177 • Number of events 4 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .
Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER