Transdermal Estradiol for Suicide
(CLEAR-4 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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a crossover trial with two perimenstrual conditions: estradiol administration and placebo, each lasting 14 days, separated by a washout cycle.
Washout
A washout cycle separates the two treatment conditions to prevent carryover effects.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Transdermal Estradiol
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Illinois at Chicago
Lead Sponsor