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

NACompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

September 30, 2000

Primary Completion Date

June 30, 2010

Study Completion Date

October 31, 2010

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.

Trial Locations (1)

06510

Yale School of Medicine, New Haven

All Listed Sponsors
collaborator

Yale University

OTHER

lead

Donaghue Medical Research Foundation

OTHER