New study shows oral contraceptive may be effective in treating severe form of premenstrual syndrome

August 22, 2001

Unique hormone provides physical and emotional relief for women with severe PMS

Results from a double-blind, placebo-controlled study published in the current issue of the Journal of Women's Health and Gender-Based Medicine show that the combination of the progestin drospirenone with the estrogen ethinyl estradiol contained in the oral contraceptive Yasmin may be beneficial in treating premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome (PMS) that affects more than 3 million U.S. women.

PMDD, a distinct medical condition characterized by severe monthly mood swings and physical symptoms that interfere with everyday life, has a noted impact on a woman's relationship with her family and friends. Cyclic symptoms of depressed mood, anxiety, irritability, breast tenderness and bloating go far beyond those associated with typical or common PMS.

PMDD sufferers experience symptoms that occur during the week or two before the menstrual period and disappear within four days of the onset of menstruation. Definitive cases include symptoms documented daily for at least two consecutive menstrual cycles.

"While oral contraceptives are among the most widely prescribed products available, they are largely understudied for the treatment of PMS and PMDD," said Dr. Andrea J. Rapkin, an author of the study and UCLA professor of obstetrics and gynecology. "The results of our study suggest that Yasmin, with its unique combination of drospirenone and ethinyl estradiol, holds promise for reducing PMDD symptoms and its disruptive and impairing affect on women's lives."

Drospirenone is different from the progestins currently available in other oral contraceptives. Drospirenone is chemically related to spironolactone, a diuretic or "water pill" widely used by gynecologists to treat fluid retention for many women. Similarly to spironolactone, drospirenone influences the regulation of water and sodium levels in the body.

Animal studies show that Yasmin also demonstrates antiandrogenic (anti-male hormone) properties that may result in a favorable effect on mild-to-moderate acne, unwanted facial hair growth and irritability.

Researchers caution that Yasmin may not be appropriate for women with kidney, liver or adrenal disease because it may increase potassium levels. Patients taking drugs that could increase potassium should consult their health-care professional before taking Yasmin.

"It is important to educate women about PMDD and let them know that they don't have to tolerate debilitating symptoms as an inevitable consequence of their menstrual cycle," said Dr. Ellen Freeman, lead author of the study and professor in the Department of Obstetrics and Gynecology at the University of Pennsylvania Medical Center. "Women should know that what they're experiencing is the result of a legitimate medical condition and that there is effective treatment available to them."

Eighty-two women aged 18-40 completed the three-month study, where the Yasmin users showed greater improvement than the placebo group. Yasmin was well tolerated, with adverse reactions typical of those associated with oral contraceptive use.

Researchers said further evaluation of Yasmin in larger placebo-controlled studies is needed to determine the extent of its effectiveness for the treatment of PMDD.
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This study was sponsored by Berlex Laboratories Inc., which makes Yasmin.

UCLA's Department of Obstetrics and Gynecology offers a full range of women's health-related services such as those for high-risk pregnancy, gynecologic cancer, reproductive endocrinology and infertility. UCLA's obstetrics-gynecology department ranks fourth in the nation and UCLA Medical Center ranks as the best hospital in the Western United States for the 12th consecutive year, according to this year's U.S. News & World Report's annual guide to "America's best hospitals."

For more information or to make an appointment, call 800-UCLA-MD1.

Contacts:
Kirsten Holguin, UCLA
kholguin@support.ucla.edu
310-794-0777

Maya Studzinski,Porter Novelli
mstudzinksi@porternovelli.com
212-601-8244

Porter Novelli

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