Actively Recruiting
Contraceptive Hormone and Reward Measurement (CHARM Study)
Led by University of Colorado, Denver · Updated on 2024-11-04
144
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand how hormonal oral contraceptives affect brain processes and emotional wellbeing in adult females. The study focuses on how a combination of synthetic estrogen and progestin may impact reward processing, mood, and sexual function. Researchers will explore changes in brain activity related to pleasure and anticipation using brain imaging techniques. Participants will be randomly assigned to one of two groups: one group will take a hormonal oral contraceptive pill daily for 21 days, and the other group will take a placebo pill that looks identical but has no active ingredients. During this three-week period, participants will complete daily check-in surveys using a computer or mobile device. They will also attend two additional visits for urine drug screening, blood tests, brain imaging (MRI), and behavioral questionnaires. Throughout the study, participants will be monitored for changes in mood, sexual function, and brain activity using specific rating scales and MRI scans. Researchers will measure changes before and after the 21-day treatment period. The entire participation lasts about three weeks, and study procedures include remote screening, medication or placebo intake, surveys, and clinical visits to collect data on how the treatment influences emotional and neural responses.
CONDITIONS
Brief Title
Contraceptive Hormone and Reward Measurement (CHARM Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 and older
- Right-handed
- Assigned female at birth
- Regular 21-35 day menstrual cycles for the past 6 months per self-report
- In generally good health per self-report; stable chronic conditions may be allowed
- Willingness to abstain from intercourse or use non-hormonal contraception during the study
- Negative urine drug screen except prescribed marijuana or benzodiazepine as sleep aid
- Ability to abstain from caffeine and/or cannabis for 2 hours before MRI visits
- Access to reliable internet or cell phone data to complete daily questionnaires
- For remote screening, access to reliable internet, a computer, and a private space
You will not qualify if you...
- Severe or unstable physical, neurological, or psychiatric disorders
- Lifetime history of psychotic disorders
- Recent substance use disorder not in remission for at least one year
- Presence of CDC category 3 or 4 conditions or medications for combined hormonal contraceptives
- Irregular menstrual periods
- Current tobacco smoking
- Personal or family history of venous thromboembolism
- Known hypertensive disorder
- Current or past malignancy
- Migraines with aura
- High blood pressure (140/90 or above) at baseline
- Currently nursing an infant
- Known chromosomal or hormonal disorder affecting sex steroids
- Recent or current hormonal contraceptive or medications affecting sex hormones
- Current pregnancy or recent pregnancy/delivery within 6 months
- Intention to become pregnant during the study
- Current use of psychotropic medication
- Claustrophobia
- Metal in body unsafe for MRI
- Weight over 300 pounds
- Any condition making MRI unsafe (e.g., aneurysm clip, pacemaker)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person or remote)
Duration - 21 days
Participants receive either oral contraceptive medication or a placebo once daily for 21 days.
1 baseline visit and 1 follow-up visit (in-person, including MRI scans and questionnaires)
Trial Site Locations
Total: 1 location
1
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
A
Andrew M Novick, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here