Transdermal Estradiol for Suicide

(CLEAR-4 Trial)

Overseen By Gabriela Guzman, M.S.

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Illinois at Chicago

Must not be taking: Exogenous hormones

Disqualifiers: Pregnancy, Chronic conditions, Smoking, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 14 days per condition, with a washout cycle in between

50 Participants Needed

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

Elizabeth Mulligan, Ph.D.

Principal Investigator

University of Illinois at Chicago

Katja M Schmalenberger, Ph.D.

Principal Investigator

University of Illinois at Chicago

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

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

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

Group I: Transdermal Estradiol Experimental Treatment 1 Intervention

.1mg per 24 hours transdermal estradiol applied to the skin weekly, for 14 days.

Group II: Placebo Placebo Group 1 Intervention

Clear patch manufactured to mimic the E2 patch applied to the skin weekly, for 14 days.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+