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FDA Approves First Pill for Heavy Menstrual Bleeding

March 16, 2012 — Estradiol valerate and estradiol valerate/dienogest (Natazia, Bayer HealthCare Pharmaceuticals Inc) oral contraceptive tablets were approved March 14 for the treatment of heavy menstrual bleeding (HMB).
According to a company press release, this agent is the first and only oral contraceptive indicated for the treatment of HMB.
The drug was approved in May 2010 for the prevention of pregnancy. The current approval was based on results from 2 multicenter, randomized, double-blind, placebo-controlled clinical trials including 421 women.
Women in the study were at least 18 years of age and were diagnosed with dysfunctional uterine bleeding, described as heavy, prolonged and/or frequent, and without organic pathology. HMB was defined as "menstrual blood loss of 80 mL or more in at least 2 bleeding episodes during a 90-day run in phase."
Patients were randomly assigned to receive either treatment or placebo for 7 menstrual cycles. Complete symptom relief during a 90-day efficacy assessment phase was reported in 29.2% and 29.5% of the treatment groups in each study compared with 2.9% and 1.2% of the placebo groups, respectively.
Overall, there was a significant reduction in blood loss for those with HMB in the treatment groups compared with those in the placebo groups (P < .0001 for both studies).
The most common adverse effects associated with treatment, present in at least 2% of treated patients, were headache/migraine, breast pain/discomfort/tenderness, menstrual disorders, nausea or vomiting, acne, mood changes, and weight gain.
Although the drug was approved for pregnancy prevention in May 2010, the contraceptive efficacy of Natazia has not been determined in women with a body mass index (BMI) greater than 30 kg/m2.
"Heavy menstrual bleeding is a common disorder reported by around three million women of reproductive age each year in the United States," Pamela A. Cyrus, MD, vice president and head of US Medical Affairs, Bayer HealthCare Pharmaceuticals, noted in a news release. "As the first oral contraceptive treatment approved for heavy menstrual bleeding in women without organic pathology who choose an OC for contraception, Natazia represents a new treatment approach for appropriate women with this medical condition."

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