Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
| Status: | Archived |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | September 2000 |
| End Date: | September 2012 |
A Double-blind, Parallel Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
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.
This is a double blind, randomized, placebo controlled, parallel study that will randomize
60 women at the Yale site into treatment. Participants will be screened at various
collaborating ob-gyn centers for possible PMS symptoms, and direct referrals from the
community will also be accepted. Subject participation length is about 7 months with 6
scheduled study visits.
Methodology: After successfully completing the screening and qualification phase,
participants will be randomized to treatment at Visit 1 for 5 cycles of double-blind
treatment. Participants will be evaluated monthly during the randomization phase for
adverse events, concurrent medication, and primary and secondary efficacy variables.
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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