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Hormone Therapy

Transdermal Estradiol for Suicide (CLEAR-4 Trial)

Phase 2

Recruiting

Led By Tory A Eisenlohr-Moul, Ph.D.

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must report at least some recent suicidal ideation (in the past month) at the time of recruitment

Assigned female at birth with intact ovaries

Timeline

Screening 3 weeks

Treatment Varies

Follow Up mean daily rating in the perimenstrual phase (days -3, -2, -1, and +1 relative to menses onset where menses onset is day +1 and there is no 0 on the menses-onset timeline) minus the mean daily rating in the early luteal phase (days +2, +3, +4, +5, and +6

Awards & highlights

CLEAR-4 Trial Summary

This trial aims to compare how two different conditions during the premenstrual period affect the severity of suicidal symptoms in women who have had thoughts of suicide in the past month but are not at immediate risk

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects from transdermal estradiol may include skin irritation at the patch site, mood swings, headache, nausea, and changes in menstrual flow or cycle length.

CLEAR-4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had thoughts about suicide in the last month.

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I was assigned female at birth and have my ovaries.

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I have not gone through menopause.

CLEAR-4 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ mean daily rating in the perimenstrual phase (days -3, -2, -1, and +1 relative to menses onset where menses onset is day +1 and there is no 0 on the menses-onset timeline) minus the mean daily rating in the early luteal phase (days +2, +3, +4, +5, and +6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~mean daily rating in the perimenstrual phase (days -3, -2, -1, and +1 relative to menses onset where menses onset is day +1 and there is no 0 on the menses-onset timeline) minus the mean daily rating in the early luteal phase (days +2, +3, +4, +5, and +6

This trial's timeline: 3 weeks for screening, Varies for treatment, and mean daily rating in the perimenstrual phase (days -3, -2, -1, and +1 relative to menses onset where menses onset is day +1 and there is no 0 on the menses-onset timeline) minus the mean daily rating in the early luteal phase (days +2, +3, +4, +5, and +6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Early-Luteal-to-Perimenstrual Increase in the Probability of Daily Suicidal Planning (SP)

Early-Luteal-to-Perimenstrual Worsening of Daily Active Suicidal Ideation (ASI)

Early-Luteal-to-Perimenstrual Worsening of Daily Passive Suicidal Ideation (PSI)

Secondary outcome measures

Early-Luteal-to-Perimenstrual Worsening of daily self-reported anhedonia

Early-Luteal-to-Perimenstrual Worsening of daily self-reported working memory failures (WMF)

Early-Luteal-to-Perimenstrual change (improvement) in daily N-Back performance

+1 more

Side effects data

From 2015 Phase 4 trial • 65 Patients • NCT00030147

Chest wall pain

Pain in extremity

100%

80%

60%

40%

20%

Study treatment Arm

Raloxifene

Estradiol

Placebo

Rimostil

CLEAR-4 Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transdermal Estradiol

2002

Completed Phase 4

~70

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

610 Previous Clinical Trials

1,559,409 Total Patients Enrolled

1 Trials studying Suicide

90 Patients Enrolled for Suicide

Tory A Eisenlohr-Moul, Ph.D.Principal InvestigatorUniversity of Illinois at Chicago

Katja M Schmalenberger, Ph.D.Principal InvestigatorUniversity of Illinois at Chicago

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals in total are enrolled as participants in this medical study?

"Indeed, information available on clinicaltrials.gov confirms the ongoing recruitment for this trial. The initial posting date was March 16th, 2024, with the latest update made on April 22nd, 2024. There is a need to enroll a total of 50 participants from one designated site."

Answered by AI

Does this study include participants older than 20 years of age?

"Eligible participants for this research must be above 20 years of age and under the age of 40."

Answered by AI

What are the main goals and purposes of this clinical investigation?

"The primary objective of this clinical research is to assess the impact on daily suicidal planning during the perimenstrual and early luteal phases. The study will analyze changes in N-Back task performance as a secondary outcome, measuring working memory capabilities. Additionally, self-reported working memory failures will be evaluated to monitor cognitive function throughout the menstrual cycle. Lastly, reward positivity (RewP) will be assessed using electroencephalography to observe neural responses to rewards and losses during a gambling task conducted in each perimenstrual phase condition."

Answered by AI

What are the safety considerations associated with Transdermal Estradiol use in patients?

"Our evaluation at Power rates the safety of Transdermal Estradiol as a 2 on a scale from 1 to 3. This score is influenced by the fact that this trial belongs to Phase 2, indicating there exists some evidence supporting its safety profile but not yet confirming its effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neurocognitive Mechanisms of Perimenstrual Estrogen Effects on Suicidality

Tory Anne Eisenlohr-Moul 2024. "Neurocognitive Mechanisms of Perimenstrual Estrogen Effects on Suicidality". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06191289.