CHARM Study: Hormonal Contraceptives, Brain Activity, and Mood
This study, called the CHARM Study, is looking at how hormonal birth control affects your brain and feelings. Researchers want to understand if taking a common birth control pill, levonorgestrel/ethinyl estradiol, changes how your brain processes rewards and impacts your mood. You would be assigned to take either levonorgestrel/ethinyl estradiol or a placebo (a pill with no medicine) for 21 days. The study aims to see if there are changes in your feelings of pleasure (anhedonia), sexual function, and brain activity after taking the pill. Women aged 18 and older, who are right-handed and have regular menstrual cycles, may be able to join. The current recruitment status is unclear.
- Study design
- This is an interventional study with 144 planned participants. You would be randomly assigned to one of two groups: either taking levonorgestrel/ethinyl estradiol or a placebo.
- What's involved
- You would have a remote screening visit to check eligibility. If eligible, you would take a pill daily for 21 days. The study will measure changes at the beginning and after 21 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures changes at baseline and after 21 days of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Contraceptive Hormone and Reward Measurement (CHARM Study)
At a glance
Conditions
NCT05058872
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Colorado Denver Anschutz Medical Campus
Aurora, Coloradostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Andrew M Novick, MD PhD · PRINCIPAL_INVESTIGATOR · University of Colorado Denver Anschutz Medical Campus
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Change in ratings of anhedonia after 21 days of receiving either levonorgestrel/ethinyl estradiol or placebo as measured by the Dimensional Anhedonia Rating ScaleBaseline, 21 days post-intervention
The Dimensional Anhedonia Rating Scale is validated measure of anhedonia (lack of pleasure, desire, and motivation). Scores range from 17 to 85 with higher scores reflecting a better outcome/less anhedonia
- Change in ratings of sexual function after 21 days of receiving either levonorgestrel/ethinyl estradiol or placebo as measured by the Female Sexual Function Index.Baseline, 21 days post-intervention
The Female Sexual Function Index is a validated questionnaire of various domains of sexual functioning in women. Scores range from 2 to 36, with higher scores reflecting better outcomes/better sexual function.
- Change in Blood Oxygen Level Dependent (BOLD) Signal after 21 days of treatment with either levonorgestrel/ethinyl estradiol or placeboBaseline, 21 days post-intervention
Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. BOLD signal in the brain will be measured during a reward task both at baseline and after 21 days of receiving either levonorgestrel/ethinyl estradiol or placebo.