CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 22 enrolled
Drug / intervention
Desogestrel and Ethinyl Estradiol Tabletsdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05002738
NCT05002738Phase 4Completed
CompareCT.gov

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

University of Colorado, Denver·interventional·Posted Aug 12, 2021·Updated May 30, 2025

In Brief

A Phase 4 clinical trial evaluating Desogestrel and Ethinyl Estradiol Tablets for Contraception. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedAug 12, 2021
Enrollment StartSep 10, 2021
Primary CompletionNov 28, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.9 years ago

Interventions

Desogestrel and Ethinyl Estradiol Tabletsdrug

Combined oral contraceptive pill