Desogestrel-containing COCP Pharmacokinetic Validation Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Validation of 24-hour Trough Concentration as a Surrogate for Intensive Pharmacokinetic Measurements for a Combined Oral Contraceptive Pill Containing Desogestrel

Conditions
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Contraception

Intervention / Treatment
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* Drug: Desogestrel and Ethinyl Estradiol Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy females aged 18-45 years Body-mass index ≥18.5kg/m2 Willing to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study Normal blood pressure measurement at screening (systolic <140mmHg, diastolic <90mmHg) Negative urine pregnancy test at screening Exclusion Criteria: Currently taking any known CYP3A4 inducers/inhibitors Medical conditions that affect liver function (e.g. hepatitis, cirrhosis) Any contraindications to estrogen-containing contraception (based on any category 3 or 4 recommendations from the CDC MEC guidelines) Use of an injectable contraceptive method within the last 6 months or current use of an ENG contraceptive implant Childbirth within the last 6 months Known allergy or insensitivity to combined oral contraceptive pills

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Overall Cohort<br>Combined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days | Drug: Desogestrel and Ethinyl Estradiol Tablets<br>* Combined oral contraceptive pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum etonogestrel concentrations | 12 serum measurements taken over the course of 24 hours | 24 hours | 
| Serum ethinyl estradiol concentrations | 12 serum measurements taken over the course of 24 hours | 24 hours |