- PERSONALIZED CARE
Generic Name (Trade Name—Company)
March 15, 2012
Estradiol valerate and dienogest
Contraceptive gains additional indication
Treatment of heavy menstrual bleeding
Bayer announced the FDA approval of its combination oral contraceptive tablet, Natazia (estradiol valerate and dienogest) for the treatment of heavy menstrual bleeding that is not caused by any diagnosed conditions of the uterus, in women who choose to use a combined oral contraceptive for contraception. This is the first and only combined oral contraceptive indicated for the treatment of heavy menstrual bleeding in the U.S.
Approval was based on data from two multicenter, double-blind, randomized, placebo-controlled trials of 421 adult women with dysfunctional uterine bleeding, characterized as heavy, prolonged and/or frequent bleeding without organic pathology. Patients were treated with for seven 28-day cycles with estradiol valerate and dienogest tablets or placebo. Both studies showed that patients treated with active drug were more likely to have complete symptom relief compared with placebo (30% vs. 1.2–2.9%). In addition, patients who were treated with active drug 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 reactions, occurring in 2% or more of patients, were headache, including migraine, breast pain/discomfort/tenderness, menstrual disorders, nausea or vomiting, acne, mood changes, and increased weight.
The tablets were originally approved in the U.S. in May 2010 for the prevention of pregnancy.