Low-Dose Birth Control Pill Treats Severe PMS

First Oral Contraceptive for PMDD May Be Approved for Sale Early Next Year

From the WebMD Archives

Aug. 31, 2005 -- A low-dose oral contraceptive that is not yet on the market may be an effective alternative to antidepressants for the treatment of severe premenstrual syndrome.

Researchers show that the unique birth control formulation worked better than placebo for treating women with premenstrual dysphoric disorder (PMDD).

Researchers from Yale University and other research centers concluded that the oral contraceptive is as effective as selective serotonin reuptake inhibitor (SSRI) antidepressants for preventing PMDD, although the two were not compared against each other.

The newly published study included 450 women with PMDD from across the country.

Yale University's Kimberly Yonkers, MD, who led the research team, reported significant symptom improvement in 48% of women with PMDD in the study who took the oral contraceptive vs. 36% of women taking placebo pills. The women were evaluated over the course of two menstrual cycles.

The findings are published in the September issue of the journal Obstetrics and Gynecology.

"I wouldn't say that this is better that antidepressants, but it does give women and their physicians another treatment option," Yonkers says. "Many women don't want to take SSRIs."

PMDD affects between 3% and 5% of menstruating women and is characterized by severe emotional and/or physical symptoms seen in the days or weeks prior to a women's period. These symptoms are similar to those seen with PMS yet significantly interfere with a woman's work and social functioning and often last longer and are more debilitating.

The SSRIs Prozac, Zoloft, and Paxil CR are approved by the FDA for the treatment of PMDD. Other SSRIs used to treat PMDD include Celexa, Effexor, and Buspar.

24 On, 4 Off

The study was funded by the oral contraceptive's manufacturer, Berlex Laboratories, which developed it as a treatment for PMDD.

Company spokeswoman Kimberly Schillace tells WebMD that Berlex is hoping to introduce the drug early next year, assuming it gets FDA approval. It will be sold under the brand name Yaz.

"We think Yaz could represent a real shift in the way PMDD is treated," she says. "Up until now women have had to rely on SSRIs to treat these symptoms. We think Yaz could be a terrific new option for women who are also looking for effective contraception."

Continued

Yaz is similar to another oral contraceptive marketed by Berlex under the brand name Yasmin, but there are important differences, Schillace says. Both contain a unique progestin that mimics the activity of a diuretic (water pill) used to treat the symptom of bloating or water retention seen in PMS.

But women who take Yaz get 24 days of active hormone followed by four days off hormones, instead of the standard 21 days of active hormone treatment followed by seven days of no hormone treatment.

Yonkers and colleagues says the shorter time off hormones offered by Yaz treatment may help women avoid severe menstrual-related symptoms.

"We know that women taking oral contraceptives often complain of symptoms like headaches, bloating, and other problems during the week that they are off hormones," she tells WebMD. "This has been broadly characterized as 'hormonal withdrawal.' It is total hypothesis at this point, but it may be that shortening the time off hormones may help women avoid this withdrawal."

SSRIs Don't Work for Everyone

Jean Endicott, PhD, says it is not clear if the new contraceptive is uniquely useful for treating PMS and PMDD because other contraceptives have not been tested.

"What we do know is that the high-dose estrogen and progestin contraceptives did not help and seemed to [promote symptoms] in some women," she says. "But that doesn't seem to be the case with the low-dose formulations."

Endicott directs the Premenstrual Evaluation Unit at Columbia Presbyterian Medical Center and is also affiliated with the New York State Psychiatric Institute.

She says the low-dose contraceptive could prove to be a useful alternative treatment for the 35% to 40% of women with PMDD who are not helped by antidepressants and for women who simply don't want to take them."

"Certainly for many women there is a stigma attached to taking antidepressants," she says. "And others are bothered by the side effects, especially the sexual side effects [seen with many SSRIs]. There is a need for more treatment options."

WebMD Health News

Sources

SOURCES: Yonkers, K.A. Obstetrics and Gynecology, September, 2005; online edition. Kimberly A. Yonkers, MD, associate professor of psychiatry, School of Epidemiology and Public Health, Yale School of Medicine, New Haven, Conn. Jean Endicott, PhD, chief of department of research assessment training, New York State Psychiatric Institute and director, Premenstrual Evaluation Unit, Columbia Presbyterian Medical Center, New York City. Kimberly Schillace, spokeswoman, Berlex Laboratories.

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