Desogestrel-containing COCP Pharmacokinetic Validation Study

Last updated: April 11, 2023
Sponsor: University of Colorado, Denver
Overall Status: Completed

Phase

4

Condition

Contraception

Treatment

N/A

Clinical Study ID

NCT05002738
21-3936
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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 CYP3A4during the study
  • Normal blood pressure measurement at screening (systolic <140mmHg, diastolic <90mmHg)
  • Negative urine pregnancy test at screening

Exclusion

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 ofan ENG contraceptive implant
  • Childbirth within the last 6 months
  • Known allergy or insensitivity to combined oral contraceptive pills

Study Design

Total Participants: 22
Study Start date:
September 10, 2021
Estimated Completion Date:
November 28, 2022

Study 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.

Connect with a study center

  • University of Colorado Denver

    Aurora, Colorado 80045
    United States

    Site Not Available

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