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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 belowSelect...
I am 18 years old or older.
Select...
I was assigned female at birth.
CHARM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 21 days post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 21 days post-intervention
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
1,752 Previous Clinical Trials
2,165,455 Total Patients Enrolled
Andrew M Novick, MD PhDPrincipal InvestigatorUniversity of Colorado Denver Anschutz Medical Campus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have irregular menstrual cycles.I have been diagnosed with high blood pressure.I am 18 years old or older.You have regular menstrual cycles.I experience migraines that come with visual disturbances.I was assigned female at birth.I have not smoked tobacco in over a year.I have a genetic or hormonal condition affecting my sex hormones.My drug test was negative, except for prescribed sleep aids.I have used hormonal contraceptives or hormone-affecting meds recently.I am 18 years old or older.I have a history of cancer.I was assigned female at birth.My drug test is clean except for prescribed sleep aids or marijuana.I or someone in my family has had a blood clot.I am currently taking medication for my mental health.You are right-handed.You are able to abstain from caffeine and/or cannabis for 2 hours prior to fMRI scan visits.
Research Study Groups:
This trial has the following groups:- Group 1: Levonorgestrel/ethinyl estradiol
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Oral Hormonal Contraceptive Use Patient Testimony for trial: Trial Name: NCT05058872 — Phase 4
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