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