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| Sponsor: | Yale University |
|---|---|
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00683605 |
Purpose
The purpose of this study is first, 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.
| Condition | Intervention |
|---|---|
|
Premenstrual Syndrome |
Drug: Fluoxetine Drug: Calcium Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Double-Blind, Parallel Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS) |
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2000 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
I: Active Comparator Fluoxetine
|
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 1200 mg of calcium.
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2: Active Comparator
Calcium
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Drug: Calcium
1200 mg of calcium will be taken for 5 menstrual cycles.
|
| 3: Placebo Comparator |
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.
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This is a two-center, double blind, randomized, placebo controlled, parallel study that will randomize 120 women 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. Our site's targetted enrollment is 60 subjects. 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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Eligibility| Ages Eligible for Study: | 18 Years to 48 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any candidate who:
Contacts and Locations| Contact: Joanne Cunningham, Ph.D. | 203-764-5719 | joanne.cunningham@yale.edu |
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Principal Investigator: | Kimberly A. Yonkers, MD | Yale University |
More Information
| Responsible Party: | Yale University School of Medicine ( Kimberly A. Yonkers, MD ) |
| Study ID Numbers: | 0001011511 |
| Study First Received: | May 19, 2008 |
| Last Updated: | May 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00683605 History of Changes |
| Health Authority: | United States: Federal Government |
|
Premenstrual syndrome, PMS, calcium |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Bone Density Conservation Agents Serotonin Uptake Inhibitors Pharmacologic Actions Fluoxetine |
Calcium, Dietary Serotonin Agents Pathologic Processes Menstruation Disturbances Therapeutic Uses Syndrome Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents Premenstrual Syndrome |