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RECRUITING
NCT05058872
PHASE4

Contraceptive Hormone and Reward Measurement (CHARM Study)

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

Summary

Purpose of this study: The purpose of this study is to learn more about how hormonal oral contraceptives affect brain processes and emotional wellbeing. Procedures: If participants agree to participate, the following will happen: 1. Eligibility visit (remote screening session) 2. If participants are eligible to participate in the study, they will be placed in one of two groups. If they are in the first group, they will be asked to take an oral contraception pill ("study drug") every day for 21 days. If they are in the second, they will take a placebo every day for 21 days. A placebo is a pill that looks like medicine but is not real and will have no medical effect on participants. Participants will not get to choose which group they are in, nor will they be told which group they are in. 3. During the three-week period in which participants will take either the study drug or placebo, they will be asked to complete daily check-in surveys on their computer or mobile device. 4. Participants will be asked to attend two additional visits over the course of about three weeks. At these visits, participants will be asked to undergo a urine drug screen, a blood draw, and a magnetic resonance imaging (MRI). They will also be asked to complete behavioral questionnaires.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2021-10-01

Completion Date

2027-03-31

Last Updated

2024-11-04

Healthy Volunteers

Yes

Interventions

DRUG

Levonorgestrel/ethinyl estradiol

Levonorgestrel 0.15mg/ethinyl estradiol 0.03mg

DRUG

Placebo

Placebo comparator

Locations (1)

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, United States