Trial Outcomes & Findings for Desogestrel-containing COCP Pharmacokinetic Validation Study (NCT NCT05002738)
NCT ID: NCT05002738
Last Updated: 2025-05-30
Results Overview
12 serum measurements taken over the course of 24 hours Correlation coefficient calculated for area under the curve versus 24-hour trough measurement
COMPLETED
PHASE4
22 participants
24 hours
2025-05-30
Participant Flow
Participant milestones
| Measure |
Overall Cohort
Combined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Cohort
n=20 Participants
Combined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days
|
|---|---|
|
Age, Continuous
|
28.3 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
|
Body-mass index
|
24.8 kg/m^2
n=20 Participants
|
PRIMARY outcome
Timeframe: 24 hours12 serum measurements taken over the course of 24 hours Correlation coefficient calculated for area under the curve versus 24-hour trough measurement
Outcome measures
| Measure |
Overall Cohort
n=20 Participants
Combined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days
|
|---|---|
|
Serum Etonogestrel Concentrations
|
0.92 correlation coefficient (r)
Interval 0.8 to 0.97
|
PRIMARY outcome
Timeframe: 24 hours12 serum measurements taken over the course of 24 hours Correlation coefficient calculated for area under the curve to 24-hour trough measurements
Outcome measures
| Measure |
Overall Cohort
n=20 Participants
Combined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days
|
|---|---|
|
Serum Ethinyl Estradiol Concentrations
|
0.86 correlation coefficient (r)
Interval 0.67 to 0.94
|
Adverse Events
Overall Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Eva Dindinger
University of Colorado Anschutz Medical Campus
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place