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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

Must not have

Known diagnosis of hypertensive disorder

Migraines with aura

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 21 days post-intervention

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with high blood pressure.

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I experience migraines that come with visual disturbances.

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I have a genetic or hormonal condition affecting my sex hormones.

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I have a history of cancer.

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I or someone in my family has had a blood clot.

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I am currently taking medication for my mental health.

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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.