WEDNESDAY, Aug. 31, 2005 (HealthDay News) -- An oral contraceptive slated to hit the U.S. market in 2006 relieves the symptoms of a severe form of premenstrual syndrome (PMS) as well as standard antidepressants do, a new study finds.
Women with premenstrual dysphoric disorder (PMDD) who also need contraception may get both pregnancy prevention and symptom relief in one pill, researchers say.
"But we don't want women to think they can stop their antidepressant without consulting their physician," said lead researcher Dr. Kimberly Yonkers, an associate professor of psychiatry at Yale University School of Medicine in New Haven, Conn. Her team's study appears in the September issue of Obstetrics & Gynecology.
Yonkers also emphasized that the study evaluated women who took the new pill against women taking a placebo -- it did not directly compare the new contraceptive, called Yaz, against antidepressants. However, the new pill provided users with about the same degree of symptom relief as antidepressants have displayed in previous studies, she said.
While many women report troublesome premenstrual symptoms such as bloating and moodiness, about 5 percent suffer from the more debilitating condition called PMDD. According to Yonkers, treatments for PMDD approved by the U.S. Food and Drug Administration are currently limited to antidepressants called serotonin reuptake inhibitors (SSRIs) such as Paxil, Prozac and Zoloft.
The low-dose oral contraceptive contains a new progestin called drospirenone, plus an estrogen, ethinyl estradiol. According to Kimberly Schillace, a spokeswoman for Berlex Laboratories in Montville, N.J., which makes Yaz and funded the study, the company got an "approvable letter" from the FDA in late 2004, with the agency asking for more data on the pill.
Yaz uses 24 days of active pills followed by 4 days of inactive or "dummy" pills to round out the cycle. That's a deviation from the standard oral contraceptive regimen, where women take an active pill for 21 days followed by inactive pills till the end of the cycle.
In the study, Yonkers' team assigned 450 women, aged 18 to 40, from 64 medical centers across the country, all diagnosed with PMDD, to either oral contraceptive or placebo. The women charted their moods and other symptoms on a daily basis.
"Symptoms of the women on the pill decreased by at least half in 48 percent, compared to just 36 percent not on it," Yonkers said. Put another way, she said, "the likelihood of response was 25 percent greater in those given active treatment vs. placebo." Women taking Yaz were more likely to report improvements in daily productivity, interpersonal relationships and enjoyment of hobbies and social activities than women not taking the drug.
"I think the data look good," said Ellen Freeman, a research professor at the University of Pennsylvania, who led a study of an earlier formulation of the same contraceptive. "They got a statistically better response in comparison to placebo," she said. "If women want contraceptive and it is OK for them to take an oral contraceptive, this appears to be a reasonable option to control PMDD."
Like Yonkers, she stressed that the new study is not a direct comparison of the antidepressant and the contraceptive. As a result, she said, "we have no way of knowing how many women who did well on an SSRI would do well on the new drug."
More information
To learn more about PMDD, visit the American Psychological Association.
