Contraceptive Hormone and Reward Measurement (CHARM Study)

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05058872
Phase
PHASE4
Status
Recruiting
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Conditions

  • Hedonic Function
  • Mood
  • Neural Activity
  • Oral Hormonal Contraceptive Use

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Levonorgestrel/ethinyl estradiol — DRUG
    Levonorgestrel 0.15mg/ethinyl estradiol 0.03mg
  • Placebo — DRUG
    Placebo comparator

Study Details

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 Dates

Start date
Oct 1, 2021
Status verified
Oct 2024
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Levonorgestrel/ethinyl estradiol
    Levonorgestrel 0.15mg/ethinyl estradiol 0.03mg - once a day for 21 days
  • Placebo Comparator: Placebo
    Placebo once a day for 21 days

Primary Outcome Measure

Change in ratings of anhedonia after 21 days of receiving either levonorgestrel/ethinyl estradiol or placebo as measured by the Dimensional Anhedonia Rating Scale [ Time Frame: Baseline, 21 days post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Denver Anschutz Medical CampusAuroraColorado80045
Andrew M Novick, MD PhD
[email protected]
2672593730

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By research site
University of Colorado Denver Anschutz Medical Campus· Aurora, CO

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