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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 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.

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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.

Conditions Studied

Mood Oral Hormonal Contraceptive Use Neural Activity Hedonic Function

Interventions

  • DRUG Placebo
  • DRUG Levonorgestrel/ethinyl estradiol

Study Locations (1)

Colorado

  • University of Colorado Denver Anschutz Medical Campus - Aurora

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2021-10-01
Est. Completion 2027-03-31
Phase Phase 4

Sponsor

University of Colorado, Denver

1,283 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05058872

The ClinicalTrials.gov registry entry for NCT05058872 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,655-participant average among 29 other Mood trials with a reported enrollment target (96% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.