title: A multicenter efficacy and safety study of an oral contraceptive containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol.
abstract: The study reported herein is the primary efficacy and safety study conducted to support U.S. registration of an oral contraceptive containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol. A large multicenter study enrolled 1,221 women at 50 centers in the United Kingdom. A total of 11,656 cycles of exposure was accumulated, corresponding to approximately 879 women-years of use. Contraceptive efficacy was high; no subject conceived as a result of method failure. The product was generally well tolerated with excellent cycle control, causing fewer than 2% of the subjects to discontinue because of bleeding irregularities. The study medication demonstrated no adverse effects on cervical cytology, blood pressure, body weight or laboratory variables, while pre-existing benign breast disease generally improved. The study did not identify any medication-related adverse experiences. This study confirmed that the monophasic oral contraceptive with 150 micrograms desogestrel and 30 micrograms ethinylestradiol is a safe and effective oral contraceptive with excellent cycle control and patient acceptability.
authors: M
authors: M
authors: Walling
mesh_terms: D000293:Adolescent; D000328:Adult; D001769:Blood / Q000187:drug effects; D001774:Blood Chemical Analysis; D001794:Blood Pressure / Q000187:drug effects; D015992:Body Mass Index; D001941:Breast Diseases / Q000188:drug therapy; D002584:Cervix Uteri / Q000166:cytology / Q000187:drug effects; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects / Q000494:pharmacology*; D017135:Desogestrel / Q000009:adverse effects / Q000494:pharmacology*; D004997:Ethinyl Estradiol / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects; D011446:Prospective Studies
chemical_list: D003277:Contraceptives, Oral, Combined; D004997:Ethinyl Estradiol; D017135:Desogestrel