Phase 4 N=22 Basic Science

Desogestrel-containing COCP Pharmacokinetic Validation Study

Contraception

Bottom Line

View on ClinicalTrials.gov: NCT05002738 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2025

Primary outcome: Primary: Serum Etonogestrel Concentrations — 0.92 correlation coefficient (r)

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Desogestrel and Ethinyl Estradiol Tablets (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Colorado, Denver
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Etonogestrel Concentrations	0.92	—
PRIMARY Serum Ethinyl Estradiol Concentrations	0.86	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05002738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.