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NCT05002738 · ClinicalTrials.gov registry record · Phase 4

Desogestrel-containing COCP Pharmacokinetic Validation Study

A Phase 4 study, sponsored by University of Colorado, Denver.

Completed
Registry status
Phase 4
Development phase
22
Enrollment target

NCT05002738: Completed Phase 4 study, sponsored by University of Colorado, Denver.

NCT05002738 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 22 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05002738, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
Phase 4
Development phase
22 participants
Enrollment target

Study 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.

Primary Outcome

12 serum measurements taken over the course of 24 hours Correlation coefficient calculated for area under the curve versus 24-hour trough measurement

Interventions

  • DRUG Desogestrel and Ethinyl Estradiol Tablets

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2021-09-10
Est. Completion 2022-11-28
Phase Phase 4
University of Colorado, Denver

1,283 total trials

What the finished NCT05002738 record still lists

NCT05002738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Desogestrel and Ethinyl Estradiol Tablets is the first listed.

NCT05002738 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05002738 about?

NCT05002738 is a clinical study titled "Desogestrel-containing COCP Pharmacokinetic Validation Study". 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 pharma...

What is the current status of trial NCT05002738?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2021-09-10. Estimated completion is 2022-11-28.

What interventions are being tested in trial NCT05002738?

The interventions under investigation include: Desogestrel and Ethinyl Estradiol Tablets (DRUG).

Who is sponsoring clinical trial NCT05002738?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05002738's enrollment target sits among peer trials

22 1731st of 2000 higher than 259 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05002738, the US trial registry maintained by the National Library of Medicine. NCT05002738 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.