Desogestrel-containing COCP Pharmacokinetic Validation Study

NCT05002738 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 21-3936
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (2)

• Serum Etonogestrel Concentrations

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

  24 hours

• Serum Ethinyl Estradiol Concentrations

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

  24 hours

Study Arms (1)

Overall Cohort

EXPERIMENTAL

Combined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days

Drug: Desogestrel and Ethinyl Estradiol Tablets

Interventions

Desogestrel and Ethinyl Estradiol Tablets DRUG

Combined oral contraceptive pill

Overall Cohort

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 37331464 DERIVED

MeSH Terms

Interventions

Desogestrel; Ethinyl Estradiol

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norpregnatrienes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Eva Dindinger
• Organization: University of Colorado Anschutz Medical Campus

eva.dindinger@cuanschutz.edu

3037242019

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 12, 2021
• Study Start: September 10, 2021
• Primary Completion: November 28, 2022
• Study Completion: November 28, 2022
• Last Updated: May 30, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)