drugset / Trial / NCT00965562

Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)

NCT00965562

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to compare the efficacy of calcium carbonate to fluoxetine in the treatment of moderate to severe PMS. Second, to compare each active agent to a placebo control. Third, to evaluate the efficacy of each treatment for specific symptom clusters (i.e. affective and somatic). Fourth, to determine whether the addition of calcium to on going fluoxetine treatment leads to additional therapeutic benefit.

Timeline

Start
2000-09
Primary completion
2010-06
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Calcium carbonate Other / unclassified 1200 mg
Comparator Fluoxetine Small molecule 20 mg

Indications