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Clinical trialNCT00318773CompletedPhase 4Interventional

Short-Term Versus Long-Term Treatment for Severe Premenstrual Syndrome (PMS)

SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Enrollment174Premenstrual Syndrome
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Department of Obstetrics/gynecology, University of Pennsylvania, School of Medicine

    Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Feb 2002
Primary completion
31 Dec 2007
Completion
29 Feb 2008
Last update posted
27 Feb 2009
Registered enrollment
174
Registry id
NCT00318773

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.