NCT05058872

Contraceptive Hormone and Reward Measurement (CHARM Study)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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 Anhedonia Rating Scale, respectively. 2. Neural activity in reward processing areas during an incentive delay task. Via functional magnetic resonance imaging, neural activity will be measured during both the anticipation and receipt of a pleasurable image (erotica, pleasant images of the outdoors, and "cute" animals). Activation of nucleus accumbens and ventromedial pre-frontal cortex is positively associated with feelings of anticipation and pleasure, respectively (10). The principal investigator hypothesizes that H2) treatment with a hormonal oral contraceptive will result in decreased activity in these regions, consistent with decreased reward anticipation and responsiveness.

Conditions

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

Interventions

Type	Name	Description
DRUG	Levonorgestrel/ethinyl estradiol	Levonorgestrel 0.15mg/ethinyl estradiol 0.03mg
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2021-10-01
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2021-09-28
• Last updated: 2024-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study