New Drug Therapy for Women with Severe PMS Studied in Clinical Trial
Drug Flutamide Reduces Activity of Testosterone and Other Androgen Hormones
Jul 25, 2005
Women with a severe form of PMS called Premenstrual Dysphoric Disorder (PMDD) can experience debilitating symptoms – including mood swings, intense anger, and impaired concentration – which interfere with their ability to function at work, at home, or in social situations. A new drug therapy for PMDD is currently being investigated in a placebo-controlled clinical trial at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. Sponsored by the National Institutes of Health (NIH), the research study will test the effectiveness of the medication flutamide, which reduces the activity of testosterone and other androgen hormones.
Flutamide has been FDA-approved for treatment of prostate disease in men, but not for treatment of PMDD.
Currently, the only FDA-approved treatments for PMDD are serotonin reuptake inhibitor (SSRI) antidepressant medications. However, 30 percent of women with PMDD do not respond to these medications, and another 20 percent of women cannot tolerate their side effects.
"There is a tremendous need for new treatments for PMDD. This disorder has been ignored, in part because premenstrual symptoms are common and usually mild. By contrast, PMDD has a significantly negative impact on patients' quality of life. This new trial may help us to better understand the cause of PMDD, which should lead to better treatments in the future," says Dr. Margaret Altemus, the study's principal investigator. Dr. Altemus is Associate Professor of Psychiatry at Weill Cornell Medical College and Associate Attending Psychiatrist at NewYork-Presbyterian/Weill Cornell.
Androgen hormones are known to promote irritability, a cardinal symptom of PMDD. Androgen hormones also can cause fluid retention, impaired concentration, and mood swings, which also are common features of PMDD.
The study is open to women (age 18-50) with severe premenstrual mood symptoms. Participating patients will be randomized to regimens of either flutamide or placebo lasting two months. At the completion of the two-month study period, participants will have the option of receiving a free two-month treatment with an SSRI antidepressant medication, known to be effective for many women with PMDD.
Interested patients may inquire about this clinical trial by phone at 212-746-3759 or by email at [email protected]. All patients will receive a free physical exam and comprehensive diagnostic evaluation.
Premenstrual Dysphoric Disorder (PMDD) is a severe form of premenstrual syndrome, which affects five percent of reproductive age women. Women with the disorder experience severe mood symptoms, which may include anger, depression, mood lability, and suicidality. Most women with PMDD also experience physical symptoms premenstrually – including bloating, fatigue, increased appetite, and clumsiness. Symptoms can persist for up to two weeks out of each month. PMDD causes substantial impairment of social and occupational functioning, and damage to family relationships.
About NewYork-Presbyterian Hospital/Weill Cornell Medical Center
The NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching Hospital NewYork-Presbyterian and its academic partner Weill Cornell Medical College. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory, and preventive care in all areas of medicine, and is committed to excellence in patient care, research, education, and community service.