CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Transdermal Estradiol + Placebo +2 moredrug
Likely dose
Transdermal Estradiol + Placebo 1mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03498313
NCT03498313Phase 4Completed
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Unique Effects of Perimenstrual Estradiol or Progesterone Supplementation on Perimenstrual Suicidality

University of Illinois at Chicago·interventional·Posted Apr 13, 2018·Updated Sep 14, 2022

In Brief

A Phase 4 clinical trial evaluating Transdermal Estradiol + Placebo, Oral Micronized Progesterone + Placebo, and 1 other intervention for Suicidal Ideation. Completed, enrolled 60 participants across 1 site.

Detailed Summary

This within-person, crossover, 3-condition, placebo-controlled study compares the impact of three perimenstrual conditions on severity of suicidal symptoms in females with past-month suicidality but minimal risk of imminent suicide attempt. The three conditions are (1) perimenstrual withdrawal from estradiol only (during progesterone stabilization), (2) perimenstrual withdrawal from progesterone only (during estradiol stabilization), and (3) perimenstrual withdrawal from both estradiol and progesterone during placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSuicidal Ideation
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedApr 13, 2018
Enrollment StartJul 27, 2018
Primary CompletionMay 9, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.2 years ago

Interventions

Transdermal Estradiol + Placebodrug

.1mg/24hr transdermal estradiol for 14 days starting day 7 after positive urine luteinizing hormone test, plus twice daily placebo pills during the same time frame.

Oral Micronized Progesterone + Placebodrug

100mg oral micronized progesterone twice daily for 14 days starting day 7 after positive urine luteinizing hormone test, plus weekly application of a placebo patch during the same time frame.

Placebosdrug

Twice daily placebo pills for 14 days starting day 7 after positive urine luteinizing hormone test, plus weekly application of a placebo patch during the same time frame.