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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00611923 |
This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.
Condition | Intervention | Phase |
---|---|---|
Premenstrual Syndrome |
Drug: Flutamide Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Androgen Hormones in PMDD |
Estimated Enrollment: | 64 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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B: Placebo Comparator
Participants will take placebo flutamide
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Drug: Placebo
Participants will take a lactose capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
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A: Experimental
Participants will take flutamide
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Drug: Flutamide
Participants will take one 125-mg flutamide capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
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Premenstrual dysphoric disorder (PMDD) is a condition that affects about 5% of menstruating women. Women with PMDD experience serious emotional and physical disturbances, which may include depression, tension, irritability, anger, anxiety, and sleep and appetite problems. Symptoms of PMDD are directly linked with the menstrual cycle, generally beginning in the latter half of the cycle and ending around the start of the next cycle. If left unmanaged, PMDD may interfere with a woman's ability to carry out normal day-to-day functioning. Current treatments for PMDD include medications, psychotherapy, and nutritional modifications. Flutamide, a medication that blocks the action of testosterone and other mood-influencing hormones, may be helpful in alleviating symptoms of PMDD. This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.
This two-phase study will last a total of 4 months and will include 7 study visits. Phase 1 will last 2 months and will include Visits 1 through 3. During Phase 1, participants will keep a daily record of symptoms, participate in a diagnostic interview, and undergo a medical history review, a physical exam, and screening laboratory tests. Eligible participants will then enter Phase 2, the treatment phase of the study.
During the treatment phase, participants will be randomly assigned to take flutamide or placebo for 2 months. Study visits will occur every 2 weeks and will include Visits 4 through 7. These visits will include discussion of side effects, symptom rating, and laboratory tests to check for pregnancy and any side effects related to liver function, blood counts, or blood chemistry. At the end of treatment with flutamide or placebo, participants will have the option of receiving treatment with sertraline, an antidepressant known to be effective for many women with PMDD. Sertraline will be given during the 2 premenstrual weeks for two cycles. If participants have already unsuccessfully tried sertraline for PMDD treatment, an alternative treatment can be attempted.
Ages Eligible for Study: | 18 Years to 48 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Diane Engel, LMSW | 212-746-3759 | die2001@med.cornell.edu |
Contact: Theresa Nguyen, NP | 212-746-4850 | mtn9001@med.cornell.edu |
United States, New York | |
New York Presbyterian Weill Cornell Medical College | Recruiting |
New York, New York, United States, 11106 |
Principal Investigator: | Margaret Altemus, MD | Weill Cornell Medical College |
Responsible Party: | Weill Cornell Medical College ( Margaret Altemus, MD ) |
Study ID Numbers: | R34 MH072878, DATR A5-ETPD |
Study First Received: | February 6, 2008 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00611923 |
Health Authority: | United States: Federal Government |
Premenstrual Dysphoric Disorder PMDD PMS |
Depression Menstruation Disturbances Mental Disorders Mood Disorders |
Flutamide Depressive Disorder Premenstrual Syndrome |
Androgen Antagonists Disease Pathologic Processes Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists |
Therapeutic Uses Syndrome Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions |