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NCT00536198 · ClinicalTrials.gov registry record · Phase 4
Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder
A Phase 4 study of Premenstrual Dysphoric Disorder, sponsored by Yale University.
- Completed
- Registry status
- Phase 4
- Development phase
- 252
- Enrollment target
- 3
- Study locations
NCT00536198: Completed Phase 4 study of Premenstrual Dysphoric Disorder, sponsored by Yale University.
NCT00536198 is a Phase 4 study of Premenstrual Dysphoric Disorder that has completed, run by Yale University. The registered enrollment target is 252 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (51% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00536198, a Phase 4 study of Premenstrual Dysphoric Disorder, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 252 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with premenstrual dysphoric disorder.
Primary Outcome
The PMTS is a 10-item scale constructed to study premenstrual syndromes. It is sensitive to change with treatment. It includes items of irritability-hostility, tension, efficiency, dysphoria, motor coordination, mental-cognitive functioning, eating habits, social impairment, sex drive, and physical symptoms. PMTS-O or PMTS-SR? Min=0 (asymptomatic), Max=40 (Highly symptomatic), higher scores indicate most severe problems
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sertraline
Study Locations (3)
Connecticut
- Yale University School of Medicine - New Haven
New York
- Cornell University, Weill Medical College - New York
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2007-11-06 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
What the finished NCT00536198 record still lists
NCT00536198 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Premenstrual Dysphoric Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00536198 reports a single indexed study location in Connecticut, New York, Virginia.
Frequently Asked Questions
What is clinical trial NCT00536198 about?
NCT00536198 is a clinical study titled "Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder". This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with premenstrual dysphoric disorder.
What is the current status of trial NCT00536198?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 252 participants. The study started on 2007-11-06. Estimated completion is 2012-02.
What conditions does trial NCT00536198 study?
This clinical trial studies the following conditions: Premenstrual Dysphoric Disorder.
What interventions are being tested in trial NCT00536198?
The interventions under investigation include: Placebo (DRUG), Sertraline (DRUG).
Who is sponsoring clinical trial NCT00536198?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00536198 being conducted?
This trial has 3 study locations across Connecticut, New York, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Premenstrual Dysphoric Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00536198's enrollment target sits among peer trials
252 339th of 2000 higher than 1,660 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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