drugset / Trial / NCT00318773
Short-Term Versus Long-Term Treatment for Severe Premenstrual Syndrome (PMS)
Phase 4
Completed
174 enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2002-02
- Primary completion
- 2007-12
- Completion
- 2008-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sertraline | Small molecule | 50 mg | — |
| Subject | Sertraline | Small molecule | 100 mg | — |