Desogestrel-containing COCP Pharmacokinetic Validation Study

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

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 Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Desogestrel and Ethinyl Estradiol Tablets

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Overall Cohort; Combined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days	Drug: Desogestrel and Ethinyl Estradiol Tablets; Combined oral contraceptive pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): November 28, 2022
• Study Completion (Actual): November 28, 2022

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Contraceptive Agents, Hormonal; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Estrogens; Contraceptives, Oral; Contraceptives, Oral, Hormonal; Contraceptives, Oral, Synthetic; Progestins; Estradiol; Ethinyl Estradiol; Desogestrel
• Other Study ID Numbers: 21-3936

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No