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

NCT00318773 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2009-02-27

No results posted yet for this 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.

Conditions

  • Premenstrual Syndrome

Interventions

DRUG

sertraline

50 - 100 mg daily for 2 weeks before each menses for 4 months or 12 months and then switched to placebo.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Ellen W Freeman, PhD · University of Pennsylvania, School of Medicine, Department of Ob/Gyn

  • Steven J Sondheimer, MD · University of Pennsylvania

  • Karl Rickels, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2007-12-31
Completion
2008-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00318773 on ClinicalTrials.gov