University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Location status: Recruiting
NCT Number: NCT05058872
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 4
Aurora, Colorado, 80045, United States
Location status: Recruiting
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Levonorgestrel 0.15mg/ethinyl estradiol 0.03mg
Placebo comparator
Time frame: Baseline, 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
Time frame: 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.
Time frame: Baseline, 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.
Contact information is provided by the study sponsor or research team.
University of Colorado, Denver
Other
Acronym: CHARM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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