NCT03720847

Effect of Perimenstrual Ovarian Steroid Supplementation on Perimenstrual Suicidality

Ovarian Hormone Withdrawal and Suicide Risk: An Experimental Approach

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A large number of observational studies have documented increased risk of suicide attempt, suicide death, and more lethal attempts during the perimenstrual (around menses) window of the female reproductive cycle; however, no experiments have investigated the causal role of ovarian steroid changes across the natural perimenstrual period in risk factors for acute suicidality. In response, the proposed experimental work investigates a causal role of perimenstrual withdrawal from the hormones estradiol (E2) and progesterone (P4) in previously-documented acute perimenstrual increases in suicidality. Participants are 30 women between the ages of 18 and 45 with current suicidal ideation but minimal risk for suicide attempt. Using a placebo-controlled, crossover within-person design, the experiment tests the hypothesis that suicidality will be heightened during natural perimenstrual E2/P4 withdrawal (under placebo), but that experimental prevention of this perimenstrual E2/P4 withdrawal (with exogenous administration of E2/P4 hormones) will prevent these perimenstrual increases in suicidality and associated risk factors.

Conditions

• Suicidal Ideation

Interventions

Type	Name	Description
DRUG	Estradiol Transdermal Patch 0.1 mg/24 hrs	Estradiol transdermal patch delivering 0.1 mg/24 hour administered by affixing to skin for 14 days starting on day 7 after ovulation
DRUG	Oral Micronized Progesterone	100 mg oral micronized progesterone taken orally twice daily for 14 days starting day 7 after ovulation
DRUG	Inactive Clear Patch	Matching placebo patch administered by affixing to skin for 14 days starting on day 7 after ovulation
DRUG	Placebo capsule	Matching placebo capsules administered twice daily for 14 days starting day 7 after ovulation

Timeline

• Start date: 2016-12-31
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2018-10-25
• Last updated: 2019-02-04
• Results posted: 2019-02-04

Locations

1 site across 1 country: United States