New Haven, Conn.-A new study led by researchers at Yale School ofMedicine shows for the first time that a low dose oral contraceptivewith a unique progestin and dosing regimen is effective in treatingsymptoms of premenstrual dysphoric disorder (PMDD), the most severeform of premenstrual syndrome.
PMDD is characterized by cyclical mood, behavioral and physicalsymptoms that can be debilitating in some women. The cause of PMDD isunknown, "although it is clear that changes in steroid hormone levelsconstitute a trigger for symptom production," said Kimberly Yonkers,M.D., associate professor in the Departments of Psychiatry andEpidemiology and Public Health and lead author of the study. She saidsymptoms are diminished by suppressing ovarian activity and can beprovoked by hormones given to women who are no longer menstruating.
The multi-center, double-blind, randomized clinical trial included 450women ages 18 to 40 from 64 medical centers across the country withsymptoms of PMDD and who were given either the oral contraceptive or aplacebo. Women who were given the oral contraceptive had significantlygreater improvement (48.4 percent compared to 36.1 percent of women onplacebo) in productivity, enjoyment of hobbies, social activities, andinterpersonal relationships, and experienced greater symptom reduction.Forty-four women from both groups withdrew from the study due toadverse effects such as nausea and intermenstrual bleeding.
The low dose oral contraceptive contains drospirenone, a new progestin,and ethinyl estradiol. It was administered for 24 days followed by fourdays of inactive pills, which is different than traditional dosingregimens that have a regimen of seven days of inactive pills. The newregimen is designed for greater ovarian suppression and a more stablehormonal environment. The women were evaluated over the course of twomenstrual cycles.
Yonkers said the results show the contraceptive is roughly as effectiveas serotonin reuptake inhibitors (SSRIs), which are commonly used asanti-depressants. "It's not necessarily better, but for women who areseeking contraception in addition to control of PMDD, this would bemore efficient because they could take one treatment," she said.
Obstetrics & Gynecology 106: 492-503 (September 2005)
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