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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 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.

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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

FieldValue
Enrollment Target 174 participants
Start Date 2002-02
Est. Completion 2008-02
Phase Phase 4

What the Registry Record Tells You About NCT00318773

The ClinicalTrials.gov registry entry for NCT00318773 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which sertraline is the first listed.

NCT00318773 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.