FDA Approved Drugs » 2012
Medical Areas: Obstetrics/Gynecology (Women’s Health) | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved March 2012
Treatment Area: heavy menstrual bleeding
Natazia is a combined oral contraceptive that contains an estrogen called estradiol valerate in combination with a progestogen called dienogest. Estradiol valerate is converted to estradiol which is the same estrogen produced in a woman’s body.
Natazia is specifically indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception.
Natazia is supplied as a series of tablets for oral administration. Natazia should be started on Day 1 of the menstrual cycle (the first day of menstrual
bleeding). One tablet should be taken orally at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or intake delayed by more than 12 hours.
The FDA approval of Natazia for heavy menstrual bleeding was based on two identically-designed, multicenter, double-blind, randomized, placebo controlled trials, one in North America and one in Europe and Australia. The studies enrolled a total of 421 adult women with a diagnosis of dysfunctional uterine bleeding characterized as heavy, prolonged and/or frequent bleeding without organic pathology. Heavy menstrual bleeding was defined as menstrual blood loss of 80 mL or more in at least two bleeding episodes during a 90-day run in phase. 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 (based on 8 strictly defined criteria during the 90-day efficacy assessment phase) was 29.2% in the Natazia group compared to 2.9% in the placebo group in the first study and 29.5% in the Natazia group compared to 1.2% in the placebo group in the second study. The subjects who received Natazia achieved a statistically significant reduction in menstrual blood loss compared with subjects who received placebo (p<0.0001 for both studies).
Adverse events associated with the use of Natazia may include, but are not limited to, the following:
Natazia is a combined oral contraceptive that contains an estrogen called estradiol valerate in combination with a progestogen called dienogest. Estradiol valerate is converted to estradiol which is the same estrogen produced in a woman’s body. It has a unique dosing approach with four progestin/estrogen dosing combinations which have been designed to deliver hormones in a novel four-phase estrogen step-down, progestin step-up regimen.
For additional information regarding Natazia or heavy menstrual bleeding, please visit the Natazia web page.