Desogestrel-containing COCP Pharmacokinetic Validation Study

Phase 4 Completed 22 enrolled University of Colorado, Denver

NaSingle-groupOpen-labelBasic science

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.

Timeline

Start: 2021-09-10
Primary completion: 2022-11-28
Completion: 2022-11-28

Publications

Lazorwitz A, Sheeder J. Validation of 24-hour trough concentration as a proxy for intensive pharmacokinetic measurements for a combined oral contraceptive pill containing desogestrel. Contraception. 2023 Oct;126:110093. doi: 10.1016/j.contraception.2023.110093. Epub 2023 Jun 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Desogestrel	Small molecule	0.15 mg	Oral
Subject	ethinyl estradiol	Small molecule	0.03 mg	Oral

Indications

No indication recorded.