Desogestrel-containing COCP Pharmacokinetic Validation Study

• Status: Not yet recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Desogestrel; Estradiol; Ethinyl Estradiol

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