NCT05002738

Desogestrel-containing COCP Pharmacokinetic Validation Study

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Desogestrel and Ethinyl Estradiol Tablets	Combined oral contraceptive pill

Timeline

• Start date: 2021-09-10
• Primary completion: 2022-11-28
• Completion: 2022-11-28
• First posted: 2021-08-12
• Last updated: 2025-05-30
• Results posted: 2025-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study