Contraceptive Hormone and Reward Measurement (CHARM Study)
University of Colorado, Denver
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.
Description
Hypothesis: The principal investigator hypothesizes that treatment with oral contraceptives, specifically a combination of a synthetic estrogen and progestin, in adult females will result in deficits in reward processing. Specific Aims: 1. Subjective ratings of mood and hedonic function. Based on previous evidence, the principal investigator hypothesizes that H1a) treatment with a hormonal oral contraceptive will result in decreased self-reports of sexual function and interest/enjoyment in non-sexual pleasurable activities as measured by the Sexual Function Questionnaire and Dimensional Anh…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Aged 18 and older; 2. Right-handed; 3. Assigned female at birth; 4. Regular 21-35 day menstrual cycles for the past 6 months per self-report; 5. In generally good health per self-report. Those with a chronic medical condition may participate at the discretion of the principal investigator if the condition is stable; 6. Willingness to abstain from intercourse or use a non-hormonal back-up method of contraception (e.g., condoms) during the entire course of the study; 7. Negative urine drug screen, excepting marijuana or benzodiazepine that is being prescribed by a physici…
Interventions
- DrugLevonorgestrel/ethinyl estradiol
Levonorgestrel 0.15mg/ethinyl estradiol 0.03mg
- DrugPlacebo
Placebo comparator
Location
- University of Colorado Denver Anschutz Medical CampusAurora, Colorado