title: Large observational trial of a new low-dose oral contraceptive containing 20 micrograms ethinylestradiol and 100 micrograms levonorgestrel (Miranova) in Germany.
abstract: The aim of this observational trial was to obtain clinical data from a large cohort of women using the new low-dose contraceptive (Miranova) and therefore to eliminate the restrictions which are normally present in clinical studies. Data were gathered in a clinical practice setting regarding cycle control and tolerance from women who were using Miranova (20 micrograms ethinylestradiol and 100 micrograms levonorgestrel). A total of 13,085 subjects were initially evaluated for this observational trial; data were available for 12,843 subjects during the treatment cycles. A total of 10,736 subjects (84.2%) completed all six treatment cycles. The method failure (Pearl index), calculated for 70,796 cycles, was 0.44. Cycle control was considered good during the trial; the length of cycle, duration of withdrawal bleeding and intensity of withdrawal bleeding did not significantly change during treatment. Intracyclic bleeding occurred mainly in the first cycle (31.4%) and declined significantly thereafter to a value of 14.5% in the third cycle. In the sixth (final) cycle, the intracyclic bleeding rate was 7.0%. There were no clinically relevant changes in mean systolic blood pressure, mean diastolic blood pressure or body weight. Miranova was shown to be an effective, well-tolerated oral contraceptive with good cycle control.
authors.affiliation: Schering Deutschland GmbH, Medical Marketing Department, Berlin, Germany.
authors.forename: R C
authors.initials: RC
authors.lastname: Hite
authors.forename: R
authors.initials: R
authors.lastname: Bannemerschult
authors.forename: P
authors.initials: P
authors.lastname: Fox-Kuchenbecker
authors.forename: R
authors.initials: R
authors.lastname: Turck
authors.forename: K
authors.initials: K
authors.lastname: Brill
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D015331:Cohort Studies; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage*; D004997:Ethinyl Estradiol / Q000008:administration & dosage*; D005260:Female; D005858:Germany; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage*; D008597:Menstrual Cycle / Q000187:drug effects*; D008875:Middle Aged; D017060:Patient Satisfaction; D011247:Pregnancy / Q000706:statistics & numerical data
chemical_list: D003277:Contraceptives, Oral, Combined; D003280:Contraceptives, Oral, Synthetic; D004997:Ethinyl Estradiol; D016912:Levonorgestrel