Research about alternative ways to measure the amount of hormones from a birth control pill

Primary Objective

This study plans to learn more about how we can best measure the amount of hormone released and circulating in an individual’s system when taking combined oral contraceptive pills (COCPs). COCPs contain both a progestin and estrogen that provide reliable birth control when taken daily. Individuals taking the same COCP will experience wide differences in the amount of hormones they are exposed to from this commonly taken drug. In order to measure that hormonal exposure, we typically need to take 12-15 samples of blood over the course of 24 hours. However, this study is designed to test if we can instead use a single blood sample to obtain equally useful data.

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Description

Participation will last up to 22 days and consist of three study visits. Participation will include taking one pack of birth control pills, containing both desogestrel and ethinyl estradiol. Participants will spend one day (8 hours) in clinic and receive an intravenous (IV) catheter for multiple blood draws. During that time, participants will have access to a TV and the internet to help pass the time. Blood will also be drawn on the final day of the study.

Main Procedures Involved: Taking birth control pills, blood draws.

Duration of Participation: 22 days

Details
Age

18 to 45 years

Eligibility

&#8226; Healthy females aged 18-45 years &#8226; Body-mass index &#8805;18.5kg/m2 o No upper body-mass index &#8226; Willing to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study9 &#8226; Normal blood pressure measurement at screening (systolic <140mmHg, diastolic <90mmHg) &#8226; Negative urine pregnancy test at screening

Type of Study

Outcomes Research

Compensation

220

Principal Investigator
Photograph of Aaron Lazorwitz,  MD, MSCS

Aaron Lazorwitz, MD, MSCS

Study ID

Protocol Number: 21-3936

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