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Neuroactive Steroid

Hormonal Therapy for Suicide Risk (CLEAR-3 Trial)

Phase 4
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
Assigned female at birth with intact ovaries
Must report at least some recent suicidal ideation (in the past month) at the time of recruitment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
Awards & highlights

CLEAR-3 Trial Summary

This trial will study how hormonal changes affect suicide risk in women, in order to develop better treatments to eliminate the monthly worsening of suicide risk that many women experience.

Who is the study for?
This trial is for premenopausal females with recent suicidal thoughts, normal menstrual cycles, and under mental health care. Participants must be at least one year postpartum, willing to use barrier birth control, have a BMI of 18-29, and be considered low risk for imminent suicide by a psychologist.Check my eligibility
What is being tested?
The study tests if stabilizing hormones using an Estradiol Transdermal Patch or Oral Micronized Progesterone can affect short-term suicide risk in women compared to placebo treatments over two weeks.See study design
What are the potential side effects?
Possible side effects may include skin irritation from the patch, hormonal changes such as mood swings or headaches, and typical risks associated with hormone therapies like bloating or fatigue.

CLEAR-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was assigned female at birth and have not had my ovaries removed.
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I have had thoughts about suicide in the last month.
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I have not gone through menopause.

CLEAR-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
This trial's timeline: 3 weeks for screening, Varies for treatment, and mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feeling suicidal (finding)
Perimenstrual Change in Daily Columbia Suicide Severity Rating Scale (C-SSRS) Screening Interview Planning Item Scores
Secondary outcome measures
Perimenstrual Change in Daily Beck Hopelessness Scale (BHS) Short Form Scores
Perimenstrual Change in Daily Brief Agitation Measure (BAM) Scores

CLEAR-3 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active condition, then Inactive conditionExperimental Treatment4 Interventions
Beginning 7 days after ovulation, active treatment begins 7 days after ovulation with an estradiol transdermal patch (0.1 mg/24 hrs) applied to the skin weekly (spanning 14 days of treatment) along with (active) 100 mg oral micronized progesterone capsules taken twice daily by mouth for 14 days. A 1-month washout is observed. Then, beginning 7 days after ovulation, inactive placebo capsules will be taken twice daily by mouth along with the application of inactive clear patches applied to the skin weekly for 14 days.
Group II: Inactive condition, then active conditionPlacebo Group4 Interventions
Beginning 7 days after ovulation, inactive placebo capsules will be taken twice daily by mouth along with the application of inactive clear patches applied to the skin weekly for 14 days. After completing a 1-month washout, active treatment begins 7 days after ovulation with an (active) estradiol transdermal patch applied to the skin weekly (spanning 14 days of treatment) along with (active) 100 mg oral micronized progesterone capsules taken twice daily by mouth for 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol Transdermal Patch 0.1 mg/24 hrs
2016
Completed Phase 4
~30
Placebo capsule
2015
Completed Phase 4
~5270
Inactive Clear Patch
2016
Completed Phase 4
~30

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
604 Previous Clinical Trials
1,558,905 Total Patients Enrolled
Tory A Eisenlohr-Moul, Ph.DPrincipal InvestigatorUniversity of Illinois at Chicago

Media Library

Estradiol Transdermal Patch 0.1 mg/24 hrs (Neuroactive Steroid) Clinical Trial Eligibility Overview. Trial Name: NCT04112368 — Phase 4
Suicidal Thoughts Research Study Groups: Active condition, then Inactive condition, Inactive condition, then active condition
Suicidal Thoughts Clinical Trial 2023: Estradiol Transdermal Patch 0.1 mg/24 hrs Highlights & Side Effects. Trial Name: NCT04112368 — Phase 4
Estradiol Transdermal Patch 0.1 mg/24 hrs (Neuroactive Steroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04112368 — Phase 4

Frequently Asked Questions

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

Is the trial open to geriatric patients?

"The target demographic for this research is individuals aged 18 years and over, with a maximum age of 45."

Answered by AI

Has the FDA given authorization to Oral Micronized Progesterone 200mg?

"The safety of Oral Micronized Progesterone 200mg is assessed at 3, as this Phase 4 trial has already been approved."

Answered by AI

What medical conditions respond positively to Oral Micronized Progesterone 200mg?

"Oral micronized progesterone 200mg is a commonly prescribed medication for absent menstrual cycles. It also has efficacy in treating hypoestrogenism, vasomotor symptoms associated with menopause, and breast-related issues."

Answered by AI

Can I join the research project?

"This clinical trial seeks ninety volunteers between 18 and 45 years of age with recent suicidal ideations. Additional prerequisites include: receiving outpatient mental health treatment at least every 3 months, being postpartum for 1 year or more, in a premenopausal state, and having experienced some degree of suicidal thoughts within the past month."

Answered by AI

How many individuals are actively involved in this investigation?

"Affirmative, the information contained on clinicaltrials.gov indicates that recruitment is in progress for this medical trial. Initially posted on September 15th 2020 and last updated August 17th 2022, the research is searching to enroll 90 volunteers at 1 site."

Answered by AI

Does this investigation currently admit participants?

"Confirmation on clinicaltrials.gov suggests that recruitment for this trial is ongoing; the study was initially made public on September 15th 2020 and most recently updated on August 17th 2022."

Answered by AI

Are there any additional investigations into the efficacy of Oral Micronized Progesterone 200mg?

"Currently, there are 82 ongoing examinations of Oral Micronized Progesterone 200mg with 16 trials in their ultimate stage. These experiments predominantly take place at Cheras and Kuala Lumpur but can be found across a total of 986 healthcare centres worldwide."

Answered by AI
~14 spots leftby Dec 2024