CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Estradiol Transdermal Patch 0.1 mg/24 hrs +3 moredrug
Likely dose
Estradiol Transdermal Patch 0.1 mg/24 hrsfrom 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/NCT03720847
NCT03720847Phase 4Completed
CompareCT.gov

Ovarian Hormone Withdrawal and Suicide Risk: An Experimental Approach

University of North Carolina, Chapel Hill·interventional·Posted Oct 25, 2018·Updated Feb 4, 2019

In Brief

A Phase 4 clinical trial evaluating Estradiol Transdermal Patch 0.1 mg/24 hrs, Oral Micronized Progesterone, and 2 other interventions for Suicidal Ideation. Completed, enrolled 30 participants across 1 site.

Detailed Summary

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) natural perimenstrual withdrawal from estradiol and progesterone (during placebo), (2) perimenstrual stabilization of estradiol and progesterone using transdermal estradiol and oral micronized progesterone.

Study Details

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

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 25, 2018
Enrollment StartDec 31, 2016
Primary CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.7 years ago

Interventions

Estradiol Transdermal Patch 0.1 mg/24 hrsdrug

Estradiol transdermal patch delivering 0.1 mg/24 hour administered by affixing to skin for 14 days starting on day 7 after ovulation

Oral Micronized Progesteronedrug

100 mg oral micronized progesterone taken orally twice daily for 14 days starting day 7 after ovulation

Inactive Clear Patchdrug

Matching placebo patch administered by affixing to skin for 14 days starting on day 7 after ovulation

Placebo capsuledrug

Matching placebo capsules administered twice daily for 14 days starting day 7 after ovulation