Desogestrel-containing COCP Pharmacokinetic Validation Study
Study Details
Study Description
Brief Summary
This study aims to validate prior pharmacokinetic research with combined oral contraceptive pill users that supports utilizing a 24-hour trough concentration as an accurate proxy for the intensive pharmacokinetic parameter of area under the curve (gold standard pharmacokinetics). The original pharmacokinetic studies were performed with a levonorgestrel-containing oral contraceptive pill and we aim to duplicate those findings with a desogestrel-containing oral contraceptive pill.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
Enrolled participants will be started on a standard pack of desogestrel-containing oral contraceptive pills and undergo an intensive pharmacokinetic study visit on day 21 of the pill pack. This will entail 11 serial blood draws and a final blood draw the next day at 24 hours post-pill intake to measure and calculate a pharmacokinetic area under the curve for both the estrogen and progestin components of the pill. We will then correlate the 24-hour trough measurement to the area under the curve measures to determine the correlation of these measurements.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Overall Cohort Combined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days |
Drug: Desogestrel and Ethinyl Estradiol Tablets
Combined oral contraceptive pill
|
Outcome Measures
Primary Outcome Measures
- Serum etonogestrel concentrations [24 hours]
12 serum measurements taken over the course of 24 hours
- Serum ethinyl estradiol concentrations [24 hours]
12 serum measurements taken over the course of 24 hours
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy females aged 18-45 years
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Body-mass index ≥18.5kg/m2
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Willing to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study
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Normal blood pressure measurement at screening (systolic <140mmHg, diastolic <90mmHg)
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Negative urine pregnancy test at screening
Exclusion Criteria:
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Currently taking any known CYP3A4 inducers/inhibitors
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Medical conditions that affect liver function (e.g. hepatitis, cirrhosis)
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Any contraindications to estrogen-containing contraception (based on any category 3 or 4 recommendations from the CDC MEC guidelines)
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Use of an injectable contraceptive method within the last 6 months or current use of an ENG contraceptive implant
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Childbirth within the last 6 months
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Known allergy or insensitivity to combined oral contraceptive pills
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Colorado Denver | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-3936