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Effect of Perimenstrual Ovarian Steroid Supplementation on Perimenstrual Suicidality

NCT03720847 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-02-04

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Tory A Eisenlohr-Moul, PhD · University of North Carolina, Chapel Hill

  • Susan Girdler, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03720847 on ClinicalTrials.gov