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NCT00318773 · ClinicalTrials.gov registry record · Phase 4
Short-Term Versus Long-Term Treatment for Severe Premenstrual Syndrome (PMS)
A Phase 4 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 4
- Development phase
- 174
- Enrollment target
NCT00318773: Completed Phase 4 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00318773 is a Phase 4 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 174 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00318773, a Phase 4 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 174 participants
- Enrollment target
Study Summary
Serotonergic antidepressants are clearly effective for premenstrual syndrome (PMS). This study compares short-term treatment (4 months) and long-term treatment (12 months) with sertraline to determine how long medication should be continued after achieving a good response, how soon symptoms return after stopping medication, and whether symptoms are further improved with long-term treatment. Multiple hypotheses include the following: The percent of relapsed subjects is greater with short-term treatment; relapse is swifter with short-term treatment; relapsed subjects improve swiftly when returned to medication; patient satisfactions and quality of life are more improved with long-term treatment.
Interventions
- DRUG sertraline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2002-02 |
| Est. Completion | 2008-02 |
| Phase | Phase 4 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00318773 record still lists
NCT00318773 is an interventional study that assigns participants to a tested intervention. The registered 174 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 (66% lower).
The record links to 0 conditions, and to 1 intervention - of which sertraline is the first listed.
NCT00318773 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00318773 about?
NCT00318773 is a clinical study titled "Short-Term Versus Long-Term Treatment for Severe Premenstrual Syndrome (PMS)". Serotonergic antidepressants are clearly effective for premenstrual syndrome (PMS). This study compares short-term treatment (4 months) and long-term treatment (12 months) with sertraline to determine how long medication should be continued after achieving a good response, how soon symptoms return a...
What is the current status of trial NCT00318773?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 174 participants. The study started on 2002-02. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00318773?
The interventions under investigation include: sertraline (DRUG).
Who is sponsoring clinical trial NCT00318773?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00318773's enrollment target sits among peer trials
174 480th of 2000 higher than 1,520 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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