Clinical Trial

Contraceptive Hormone and Reward Measurement (CHARM Study)

Study acronym: CHARM
Recruiting Phase 4
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-09-17; most recent amendment 2024-10-31.
Trial Details
NCT Number NCT05058872
Lead Sponsor University of Colorado, Denver
Conditions Oral Hormonal Contraceptive Use, Neural Activity, Mood, Hedonic Function
Enrollment 144 participants
Start Date 2021-10-01
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-04