Desogestrel-containing COCP Pharmacokinetic Validation Study

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 4

Conditions: Contraception

Treatments: Drug: Desogestrel and Ethinyl Estradiol Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT05002738

21-3936

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

22 participants in 1 patient group

Overall Cohort

Experimental group

Description:

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

Treatment:

Drug: Desogestrel and Ethinyl Estradiol Tablets