drugset / Trial / NCT00965562
Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Calcium carbonate | Other / unclassified | 1200 mg | — |
| Comparator | Fluoxetine | Small molecule | 20 mg | — |