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Hormone Therapy

Hormonal Contraceptives for Depression (CHARM Trial)

Phase 4
Recruiting
Led By Andrew M Novick, MD PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 and older
Assigned female at birth
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 21 days post-intervention
Awards & highlights

CHARM Trial Summary

This trial is studying how hormonal oral contraceptives affect brain processes and emotional wellbeing. If you agree to participate, you will take a pill every day for 21 days. You may be taking the study drug or a placebo, and you will not be told which you are taking. You will complete daily check-in surveys and attend two additional visits.

Who is the study for?
The CHARM Study is for right-handed females aged 18+, with regular menstrual cycles and good health. Participants must not smoke, have a history of severe disorders, or use hormonal contraceptives recently. They should be willing to avoid intercourse or use non-hormonal contraception during the study.Check my eligibility
What is being tested?
This trial tests how oral contraceptives affect brain activity and mood. Participants will take either an oral contraceptive pill or a placebo daily for three weeks while completing surveys and undergoing MRI scans, urine tests, blood draws, and questionnaires.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include typical reactions to oral contraceptives such as nausea, headaches, mood changes, or other hormone-related effects.

CHARM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I was assigned female at birth.

CHARM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 21 days post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 21 days post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Blood Oxygen Level Dependent (BOLD) Signal after 21 days of treatment with either levonorgestrel/ethinyl estradiol or placebo
Change in ratings of anhedonia after 21 days of receiving either levonorgestrel/ethinyl estradiol or placebo as measured by the Dimensional Anhedonia Rating Scale
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.

CHARM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Levonorgestrel/ethinyl estradiolExperimental Treatment1 Intervention
Levonorgestrel 0.15mg/ethinyl estradiol 0.03mg - once a day for 21 days
Group II: PlaceboPlacebo Group1 Intervention
Placebo once a day for 21 days

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,382 Total Patients Enrolled
Andrew M Novick, MD PhDPrincipal InvestigatorUniversity of Colorado Denver Anschutz Medical Campus

Media Library

Levonorgestrel/ethinyl estradiol (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05058872 — Phase 4
Oral Hormonal Contraceptive Use Research Study Groups: Levonorgestrel/ethinyl estradiol, Placebo
Oral Hormonal Contraceptive Use Clinical Trial 2023: Levonorgestrel/ethinyl estradiol Highlights & Side Effects. Trial Name: NCT05058872 — Phase 4
Levonorgestrel/ethinyl estradiol (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05058872 — Phase 4
Oral Hormonal Contraceptive Use Patient Testimony for trial: Trial Name: NCT05058872 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in the research initiative?

"Affirmative, the information on clinicaltrials.gov demonstrates that this experiment is currently enlisting volunteer participants. The study initiated its recruitment process on September 20th 2021 and was recently updated on January 25th 2022. Currently, 80 people are needed to participate at a single site."

Answered by AI

Does my profile qualify me to partake in the current research?

"This clinical trial is recruiting 80 individuals aged 18-45 that possess a satisfactory level of hedonic function. To participate, subjects must present with a negative drug screening result (barring marijuana and benzodiazepine if prescribed for sleep), have avoided caffeine/cannabis in the two hours preceding an fMRI scan, be right handed, assigned female at birth, report regular menstrual cycles over the last 6 months, declare themselves as generally healthy or having stable chronic medical conditions; commit to abstaining from intercourse/using non-hormonal contraception during their participation period; gain access to internet connection & computer equipment for remote consenting sessions;"

Answered by AI

To what degree can Levonorgestrel/ethinyl estradiol put patients at risk?

"The safety of Levonorgestrel/ethinyl estradiol is rated at a 3, given that this medication has been approved by the Phase 4 trial."

Answered by AI

Is this research experiment seeking out elderly individuals as participants?

"This trial stipulates that applicants must fit into the 18 to 45 age bracket. Additionally, there are 6 trials for minors and 16 studies exclusively for seniors over 65 years old."

Answered by AI

Are there any other research initiatives exploring the effects of Levonorgestrel/ethinyl estradiol?

"Presently, there are 14 clinical trials surrounding Levonorgestrel/ethinyl estradiol with 3 of those in the final phase. Of all these research projects, a considerable number take place in Aurora, Colorado. Overall, this medication is being studied in 14 different locations across the globe."

Answered by AI

What is the typical application of Levonorgestrel/ethinyl estradiol?

"Levonorgestrel/ethinyl estradiol is a commonly prescribed medication for post-partum mothers, as well as individuals experiencing hormonal imbalances associated with contraception, endometrial hyperplasia and acne vulgaris."

Answered by AI

Are there any current opportunities for enrolment in this clinical trial?

"Affirmative. Evidenced on clinicaltrials.gov, this medical experiment is presently recruiting participants from one location and needs a total of 80 volunteers - it first appeared online September 20th 2021 and was last updated January 25th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
What site did they apply to?
University of Colorado Denver Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

I'm testing out your website. I want to address my depression and actually feel and see improvements in my mood, and I just haven't found that yet - and my doctors seem to just pick whatever. By doing this trial, I get to pick, and this is a drug is one I am actually interested in trying.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Contraceptive Hormone and Reward Measurement (CHARM Study)
2021. "Contraceptive Hormone and Reward Measurement (CHARM Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05058872.
~78 spots leftby Mar 2027
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