Desogestrel-containing COCP Pharmacokinetic Validation Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2022-11-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Contraception

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Overall Cohort

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

Group Type EXPERIMENTAL

Desogestrel and Ethinyl Estradiol Tablets

Intervention Type DRUG

Combined oral contraceptive pill

Interventions

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Desogestrel and Ethinyl Estradiol Tablets

Combined oral contraceptive pill

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes