Desogestrel-containing COCP Pharmacokinetic Validation Study

Phase 4

Completed

• Conditions: Contraception
• Interventions: Drug: Desogestrel and Ethinyl Estradiol Tablets

• Registration Number: NCT05002738
• Lead Sponsor: University of Colorado, Denver

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.

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 Timeline

• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-12
• Study Start: 2021-09-10
• Primary Completion: 2022-11-28
• Study Completion: 2022-11-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Overall Cohort	Desogestrel and Ethinyl Estradiol Tablets	Combined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States