Natazia approved for heavy menstrual bleeding
The FDA has approved the oral contraceptive, Natazia (estradiol valerate and estradiol valerate/dienogest; Bayer), to treat women with heavy menstrual bleeding (HMB) that is not caused by a diagnosed condition of the uterus.
This new indication makes Natazia the first oral contraceptive approved for the treatment of HMB, Bayer said in a press release. The approval was based on findings from two randomized multicenter clinical trials that included 481 women with a diagnosis of dysfunctional uterine bleeding characterized as heavy, prolonged and/or frequent bleeding without organic pathology.
A higher proportion of participants treated with Natazia for seven 28-day cycles achieved complete symptom relief than those assigned to placebo -- 29.2% vs. 2.9% in the first study, and 29.5% vs. 1.2% in the second study. Patients with HMB (defined as menstrual blood loss of 80 mL or more in at least 2 bleeding episodes during a 90-day run in phase) who were treated with Natazia achieved a statistically significant reduction in menstrual blood loss compared with patients in the placebo group (P<0.0001 for both studies).
The most common adverse events included headache/migraine, breast pain/discomfort/tenderness, menstrual disorders, nausea or vomiting, acne, mood changes and weight gain.Natazia was first approved in May 2010 for the prevention of pregnancy. It is the first oral contraceptive that contains an estrogen called estradiol valerate and a progestin called dienogest. Estradiol valerate is a synthetic estrogen that is converted to estradiol in a woman's body.