Evaluation of a new estradiol oral contraceptive: estradiol valerate and dienogest.
BACKGROUND
Since ethinyl estradiol is a potent activator of hepatic enzymes, the use of natural estradiol (E2) has been studied; but, until recently, bleeding control has hampered development of an E2 pill.


METHODS
A historical review of oral contraceptive development leading to the successful design of an estradiol pill. Pharmacology, mechanism of action and clinical trials of contraceptive efficacy and bleeding profile of the estradiol valerate/dienogest (E2V/DNG) pill are reviewed. Details of two placebo-controlled treatment trials of the E2V/DNG pill in women with heavy menstrual bleeding are discussed. All available literature was searched using pubMed and additional data were obtained from published abstracts.


RESULTS
Information on the novel features and indications for the E2V/DNG pill.


CONCLUSIONS
The dynamic-dosing E2V/DNG oral contraceptive pill provides a highly effective contraceptive option with an adjusted Pearl Index (method failure) of 0.51 (upper limit of 95% CI 0.97) and unadjusted Pearl Index (user failure) of 1.01 (1.59) for women aged 18-35 years. In addition, two large randomized controlled trials have demonstrated that E2V/DNG provides effective treatment for women with heavy menstrual bleeding.
Jensen
Jeffrey T
JT
Oregon Health & Science University, Department of Obstetrics and Gynecology, UHN-70, OHSU, 3181 SW Sam Jackson Park Road, Portland, Oregon 97239, USA. jensenje@ohsu.edu
D000293:Adolescent; D000328:Adult; D002986:Clinical Trials as Topic; D003277:Contraceptives, Oral, Combined / Q000494:pharmacology / Q000627:therapeutic use*; D004338:Drug Combinations; D015195:Drug Design; D004958:Estradiol / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008595:Menorrhagia / Q000188:drug therapy; D009277:Nandrolone / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D011247:Pregnancy; D049168:Pregnancy, Unplanned; D055815:Young Adult
D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C454300:estradiol valerate-dienogest; D004958:Estradiol; D009277:Nandrolone