FDA approves first oral contraceptive to treat heavy menstrual bleeding

FDA has approved a new indication for estradiol valerate and estradiol valerate/dienogest (Natazia, Bayer HealthCare Pharmaceuticals) tablets for the treatment of heavy menstrual bleeding (HMB) that is not caused by any diagnosed conditions of the uterus.

Natazia is the first and only oral contraceptive indicated for the treatment of HMB.

Natazia was approved in May 2010 for the prevention of pregnancy. The contraceptive efficacy of Natazia has not been evaluated in women with a body mass index greater than 30 kg/m2.

Heavy menstrual bleeding reportedly is a common disorder reported by around 3 million women of reproductive age each year in the United States.

The approval of Natazia for this HMB indication was based on 2 identically designed, multicenter, double-blind, randomized, placebo-controlled trials - 1 in North America and 1 in Europe and Australia. The studies included a total of 421 women aged 18 years or older with a diagnosis of dysfunctional uterine bleeding characterized as heavy, prolonged, and/or frequent bleeding without organic pathology.

Subjects were treated for seven 28-day cycles with either Natazia or placebo. The proportion of the intent-to-treat subjects with complete symptom relief was 29.2% in the Natazia group compared to 2.9% in the placebo group In the first study, based on 8 strictly defined criteria for success during the 90-day efficacy assessment phase.

In the second study, the proportion was 29.5% in the Natazia group compared to 1.2% in the placebo group.

Patients with HMB who were treated with Natazia achieved a statistically significant reduction in menstrual blood loss compared with patients in the placebo group (P

Most common adverse reactions (greater than or equal to 2%) in Natazia clinical trials included headache/migraine, breast pain/discomfort/tenderness, menstrual disorders, nausea or vomiting, acne, mood changes, and weight gain.

Natazia increases the risk of serious conditions including blood clots, stroke, and heart attack. The risk of blood clots is highest during the first year of use. This risk is greatest when first starting the Pill and when restarting the same or a different pill after a break of 4 weeks or greater.