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NCT03498313 · ClinicalTrials.gov registry record · Phase 4
Unique Effects of Perimenstrual Estradiol or Progesterone Supplementation on Perimenstrual Suicidality
A Phase 4 study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT03498313: Completed Phase 4 study, sponsored by University of Illinois at Chicago.
NCT03498313 is a Phase 4 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03498313, a Phase 4 study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
Each day, participants completed five items from the Adult Suicidal Ideation Questionnaire (ASIQ; items 1,2,9,17,19). Response options ranged from 1 (no suicidal ideation) to 6 (extreme severity of suicidal ideation). For each participant on each day, "mean daily SI" was calculated as the mean of these five items. Our outcome, Cyclical Change in SI Severity, is calculated for each person, in each condition, as the DIFFERENCE between mean daily SI during the low-risk early luteal phase days (day
Interventions
- DRUG Placebos
- DRUG Transdermal Estradiol + Placebo
- DRUG Oral Micronized Progesterone + Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2018-07-27 |
| Est. Completion | 2021-05-09 |
| Phase | Phase 4 |
What the finished NCT03498313 record still lists
NCT03498313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebos is the first listed.
NCT03498313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03498313 about?
NCT03498313 is a clinical study titled "Unique Effects of Perimenstrual Estradiol or Progesterone Supplementation on Perimenstrual Suicidality". 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 ...
What is the current status of trial NCT03498313?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2018-07-27. Estimated completion is 2021-05-09.
What interventions are being tested in trial NCT03498313?
The interventions under investigation include: Placebos (DRUG), Transdermal Estradiol + Placebo (DRUG), Oral Micronized Progesterone + Placebo (DRUG).
Who is sponsoring clinical trial NCT03498313?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03498313's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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