drugset / Trial / NCT03498313

Unique Effects of Perimenstrual Estradiol or Progesterone Supplementation on Perimenstrual Suicidality

NCT03498313 ↗

RandomizedCrossoverDouble-blindBasic science

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.

Timeline

Start
2018-07-27
Primary completion
2021-05-09
Completion
2021-05-09

Outcome

Mixed primary results

registry Transdermal Estradiol + Placebo vs Placebos; p = .002; Slope -.25 (95% CI -.41 to -.08) NCT03498313 ↗

registry Oral Micronized Progesterone + Placebo vs Placebos; p = .46; Slope -.06 (95% CI -.22 to .10) NCT03498313 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified 0.1 mg Other
Subject Progesterone Other / unclassified 100 mg —

Indications

No indication recorded.