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Oct 5, 2006

First Oral Contraceptive Approved to Treat Symptoms of Premenstrual Dysphoric Disorder

  • Berlex reported that the FDA approved YAZ® (3-mg drospirenone/20-mcg ethinyl estradiol) as the first oral contraceptive for the treatment of emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who use oral contraceptives.

    “For years, women overwhelmingly told us that they want more from their birth control pill than just reliable contraception,” says Reinhard Franzen, president and CEO. “Very high on their list of desired added benefits was the relief from the impact of menstrual symptoms. We knew that our innovative progestin drospirenone held promise due to its unique properties. We are very happy that we can now offer YAZ as an effective contraceptive, as well as a treatment for mood swings, bloating, and other symptoms of PMDD.”

    YAZ combines progestin drospirenone with 20-mcg of ethinyl estradiol in a 24-day active hormone pill regimen. The 30-hour half life of drospirenone combined with the 24-day active hormone pill regimen results in less hormonal fluctuation during the menstrual cycle, explains Berlex.

    In a multicenter, double-blind, randomized, parallel clinical trial of 450 women aged 18–40 with symptoms of PMDD, YAZ was significantly superior to placebo in improving interpersonal relationships, work productivity, and enjoyment of hobbies/social activities, according to Berlex. The company adds that YAZ decreased the severity of symptoms by at least half in 48% of the patients.



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