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

NCT00965562 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2015-03-23

Study results available
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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.

Conditions

  • Premenstrual Syndrome

Interventions

DRUG

Fluoxetine

Fluoxetine 20 mg per day for 4 menstrual cycles. For the fifth menstrual cycle, all women will receive calcium. Women on Fluoxetine will continue taking it in addition to 1200mg of calcium.

DRUG

Calcium

1200 mg of calcium to be taken for 5 menstrual cycles.

DRUG

Placebo

For 5 cycles, women will receive placebo. At the end of the fourth cycle, all women will receive 1200 mg of calcium in addition to the placebo medication.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • Donaghue Medical Research Foundation

    lead OTHER

Principal Investigators

  • Kimberly A Yonkers, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2010-06-30
Completion
2010-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00965562 on ClinicalTrials.gov