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Contraceptive Hormone and Reward Measurement (CHARM Study)

Study acronym: CHARM
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contact updatedv6
  2. Primary and study completion dates: Sep 27, 2025 to Mar 31, 2027v5
  3. Enrollment target: 80 to 144 Primary and study completion dates: Sep 27, 2023 to Sep 27, 2025 · Start date: Sep 20, 2021 to Oct 1, 2021v4 Show 2 more changesShow less
    • Primary and study completion dates: Sep 27, 2023 to Sep 27, 2025
    • Start date: Sep 20, 2021 to Oct 1, 2021
  4. Eligibility criteria expanded, about 1 wordv3 See this version in full on ClinicalTrials.gov ↗
  5. Start date changed from estimate of Sep 2021 to Sep 20, 2021v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov