By Yael Waknine
Medscape Medical News

May 7, 2010 — The US Food and Drug Administration (FDA) has approved a combination hormonal contraceptive tablet containing estradiol valerate and dienogest (Natazia; Bayer HealthCare Pharmaceuticals).

The product offers 4 progestin/estrogen dosing combinations during each 28-day cycle and is the first "4-phasic" oral contraceptive to be marketed in the United States. It also is the first contraceptive to contain the bioidentical synthetic estrogen estradiol valerate, rather than ethinyl estradiol.

"Nearly 12 million women in the United States and more than 100 million women worldwide currently use oral contraceptives," said Scott Monroe, MD, director of the FDA's Division of Reproductive and Urologic Products, in an agency news release. "The approval of Natazia provides another option for women who choose to use an oral contraceptive as their method of contraception."

FDA approval was based on data from 2 multicenter, open-label, single-arm phase 3 studies in which 1867 women with a body mass index of 30 kg/m2 or less underwent nearly 30,000 treatment cycles in North America and Europe.

The Pearl Index (PI) was the primary measure for assessing contraceptive reliability, based on FDA criteria for pregnancies that occur in women aged 18 to 35 years during cycles 1 to 13, including pregnancies at 7 days posttreatment.

Results from the North America trial (3969 exposure cycles) and European trial (11,275 exposure cycles) showed contraceptive failure rates at 1 year of 0.016 (5 pregnancies; PI, 1.64) and 0.010 (9 pregnancies; PI, 1.04), respectively, which are similar to those of other hormonal contraceptives containing 20 μg ethinyl estradiol.

Adverse events most commonly (?2%) reported with estradiol valerate/dienogest use included headache, including migraines (13.2%); metrorrhagia and irregular menstruation (8.0%); breast pain, discomfort, or tenderness (6.6%); nausea/vomiting (6.5%); acne (3.9%); and weight gain (2.8%).

As with other oral contraceptives, the safety labeling for estradiol valerate/dienogest strongly advises that women not smoke because of an increased risk for serious cardiovascular events that increases with age and number of cigarettes, particularly for those older than 35 years.

Estradiol valerate/dienogest contraceptive tablets (marketed as Qlaira) previously were approved for use in the European Union and are also being studied for the treatment of excessive, prolonged, and frequent menstrual bleeding.

作者:Yael Waknine

出處:WebMD醫學新聞


  【24drs.com】May 7, 2010 — 美國食品藥物管理局(FDA)核准一個複方荷爾蒙避孕藥錠劑,含有estradiol valerate和dienogest (商品名Natazia;Bayer HealthCare Pharmaceuticals藥廠)。
  
  在每個28天療程內,這個產品提供四種黃體素/雌激素劑量組合,是第一種在美國行銷上市的四階段口服避孕藥,也是第一個含有生物同質性合成雌激素、estradiol valerate的避孕藥,而非ethinyl estradiol。
  
  FDA生殖與泌尿產品小組主任Scott Monroe醫師在該局的新聞稿中表示,美國將近1200萬名婦女以及全球超過1億名婦女目前有在使用口服避孕藥,在口服避孕藥使用上,Natazia的核准可提供這些婦女另一種選擇。
  
  FDA的核准是根據兩個多中心、開放標籤、單一組別的第3期研究資料,共有1867名婦女、身體質量指數30 kg/m2或以下,在北美和歐洲共接受了將近30,000次的治療。
  
  珀爾指數(PI)是評估避孕信賴度的主要方式,根據FDA的懷孕準則,18- 35歲婦女在1-13療程內發生懷孕,包括治療後7天內的懷孕。
  
  北美試驗(3969 exposure cycles)和歐洲試驗(11,275 exposure cycles)的結果顯示,一年避孕失敗的比率分別是0.016 (5例懷孕;PI,1.64)以及0.010 (9例懷孕;PI,1.04),和那些含20 μg ethinyl estradiol的其他荷爾蒙避孕藥效果相似。
  
  與使用estradiol valerate/dienogest相關的常見(≧2%)副作用,包括頭痛、偏頭痛(13.2%);子宮出血以及月經不規律(8.0%);乳房痛、不適或壓痛(6.6%);噁心/嘔吐(6.5%);青春痘(3.9%);體重增加(2.8%)。
  
  如同其他口服避孕藥,estradiol valerate/dienogest的安全標示強烈建議婦女不要抽菸,因為嚴重心血管事件的風險隨著年紀和抽菸量增加而增加,特別是那些35歲以上者。
  
  Estradiol valerate/dienogest 避孕藥(行銷名稱為Qlaira)之前被歐盟核准使用,也被研究用來治療過量或延長或頻繁的月經出血。

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