50 Participants Needed

Transdermal Estradiol for Suicide

(CLEAR-4 Trial)

TA
GG
Overseen ByGabriela Guzman, M.S.
Age: 18 - 65
Sex: Female
Trial Phase: Phase 2
Sponsor: University of Illinois at Chicago
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This within-person, crossover, 2-condition, placebo-controlled study compares the impact of two perimenstrual conditions on severity of suicidal symptoms in females with past-month suicidality but minimal risk of imminent suicide attempt. The two conditions are (1) perimenstrual administration of estradiol and (2) natural perimenstrual withdrawal from estradiol during placebo.

Research Team

EM

Elizabeth Mulligan, Ph.D.

Principal Investigator

University of Illinois at Chicago

KM

Katja M Schmalenberger, Ph.D.

Principal Investigator

University of Illinois at Chicago

TA

Tory A Eisenlohr-Moul, Ph.D.

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

This trial is for premenopausal females who were assigned female at birth, have intact ovaries, and a normal weight. Participants must have had suicidal thoughts in the past month but are not at immediate risk of suicide. They should speak English, have regular menstrual cycles, be under mental health care with quarterly visits minimum, and agree to use barrier contraception during the study.

Inclusion Criteria

Speaks English
Ability to adhere to medication regimen
Willing to use a barrier method of birth control during the study
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Exclusion Criteria

Must not be pregnant, breastfeeding, or trying to become pregnant
Must not report a history of clinical diagnosis or treatment for postpartum depression or premenstrual dysphoric disorder (Note: Premenstrual Dysphoric Disorder diagnosis must have been made based on prospective daily ratings)
Any current cigarette smoking is exclusionary
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a crossover trial with two perimenstrual conditions: estradiol administration and placebo, each lasting 14 days, separated by a washout cycle.

14 days per condition, with a washout cycle in between

Washout

A washout cycle separates the two treatment conditions to prevent carryover effects.

1 menstrual cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Transdermal Estradiol
Trial Overview The study tests how perimenstrual estradiol affects suicidality by comparing two conditions: applying transdermal estradiol patches or using a placebo during the natural drop in estrogen before menstruation. It's designed as a crossover trial where participants experience both conditions.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transdermal EstradiolExperimental Treatment1 Intervention
.1mg per 24 hours transdermal estradiol applied to the skin weekly, for 14 days.
Group II: PlaceboPlacebo Group1 Intervention
Clear patch manufactured to mimic the E2 patch applied to the skin weekly, for 14 days.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+
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