Desogestrel-containing COCP Pharmacokinetic Validation Study

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05002738
• Other study ID #: 21-3936
• Status: Completed
• Phase: Phase 4
• Start date: September 10, 2021
• Est. completion date: November 28, 2022

Study information

• Verified date: April 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 28, 2022
• Est. primary completion date: November 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Desogestrel and Ethinyl Estradiol Tablets
Combined oral contraceptive pill

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum etonogestrel concentrations	12 serum measurements taken over the course of 24 hours	24 hours
Primary	Serum ethinyl estradiol concentrations	12 serum measurements taken over the course of 24 hours	24 hours