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NCT05058872 · ClinicalTrials.gov registry record · Phase 4
Contraceptive Hormone and Reward Measurement (CHARM Study)
A Phase 4 study of Mood and Oral Hormonal Contraceptive Use, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 144
- Enrollment target
- 1
- Study location
NCT05058872: Recruiting Phase 4 study of Mood and Oral Hormonal Contraceptive Use, sponsored by University of Colorado, Denver.
NCT05058872 is a Phase 4 study of Mood and Oral Hormonal Contraceptive Use that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 144 participants, below the 3,655-participant average among 29 other Mood trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05058872, a Phase 4 study of Mood and Oral Hormonal Contraceptive Use, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 144 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Levonorgestrel/ethinyl estradiol
Study Locations (1)
Colorado
- University of Colorado Denver Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 4 |
What NCT05058872 shows while recruiting
NCT05058872 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 3,655-participant average among 29 other Mood trials with a reported enrollment target (96% lower).
The record links to 4 conditions, with Mood appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05058872 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05058872 about?
NCT05058872 is a clinical study titled "Contraceptive Hormone and Reward Measurement (CHARM Study)". 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 a...
What is the current status of trial NCT05058872?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 144 participants. The study started on 2021-10-01. Estimated completion is 2027-03-31.
What conditions does trial NCT05058872 study?
This clinical trial studies the following conditions: Mood, Oral Hormonal Contraceptive Use, Neural Activity, Hedonic Function.
What interventions are being tested in trial NCT05058872?
The interventions under investigation include: Placebo (DRUG), Levonorgestrel/ethinyl estradiol (DRUG).
Who is sponsoring clinical trial NCT05058872?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05058872 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05058872's enrollment target sits among peer trials
144 7th of 29 higher than 23 of 29 other Mood trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mood trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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