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Completed

NCT Number: NCT05002738

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 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.

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Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 CYP3A4 during the study
  • Normal blood pressure measurement at screening (systolic <140mmHg, diastolic <90mmHg)
  • Negative urine pregnancy test at screening

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

Treatment and study plan

Desogestrel and Ethinyl Estradiol Tablets

Drug

Combined oral contraceptive pill

Primary outcomes

  1. Serum Etonogestrel Concentrations

    Time frame: 24 hours

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

  2. Serum Ethinyl Estradiol Concentrations

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2021
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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