title: Comparison of efficacy, cycle control, and tolerability of two low-dose oral contraceptives in a multicenter clinical study.
abstract: This study compares the contraceptive reliability, cycle control, and tolerability of two oral contraceptive preparations containing 20 micrograms of ethinyl estradiol combined with either 75 micrograms of gestodene (EE/GSD) or 150 micrograms of desogestrel (EE/DSG). Women received the trial preparations daily for 21 days, followed by a 7-day pill-free interval. Contraceptive efficacy, cycle control, and tolerability were evaluated over a period of 12 cycles. Efficacy data of 14,700 treatment cycles (EE/GSD: 7299; EE/DSG: 7401) were obtained from 1476 women (EE/GSD, n = 740; EE/DSG, n = 736). Both preparations provided effective contraception and good cycle control with a similarly low incidence of both spotting and breakthrough bleeding. The spotting rates in both treatment groups decreased from 35.1% (EE/GSD) and 37.5% (EE/DSG) in the first treatment cycle to approximately 10% in the fourth treatment cycle. The spotting incidence as percent of the total number of cycles was 12.7% for EE/GSD and 14.3% for EE/DSG. The breakthrough bleeding incidence was 5.2% of all cycles for EE/GSD and 6.0% of all cycles for EE/DSG. For 84.7% of the cycles in the gestodene group and for 82.5% of the cycles in the desogestrel group, neither spotting nor breakthrough bleeding were recorded. Overall, the spotting and breakthrough bleeding incidence tended to be lower with EE/GSD than with EE/DSG. However, the difference was not statistically significant. Amenorrhea was recorded in 2.7% of the cycles with EE/GSD and in 2.9% with EE/DSG. Both preparations were well tolerated and showed a similar pattern of adverse events. More than 83% of the women in both groups either did not gain weight or lost more than 2 kg. Both preparations had a beneficial effect on dysmenorrhea. Both regimens provided reliable contraception and good cycle control. The incidence of adverse events was relatively low and both preparations were well tolerated.
authors.affiliation: Department for Gynecology and Obstetrics, University of Heidelberg, Germany. jan.endrikat@schering,de
authors.forename: J
authors.initials: J
authors.lastname: Endrikat
authors.forename: B
authors.initials: B
authors.lastname: Düsterberg
authors.forename: A
authors.initials: A
authors.lastname: Ruebig
authors.forename: C
authors.initials: C
authors.lastname: Gerlinger
authors.forename: T
authors.initials: T
authors.lastname: Strowitzki
mesh_terms: D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects; D017135:Desogestrel / Q000008:administration & dosage; D045166:Estradiol Congeners / Q000008:administration & dosage; D004997:Ethinyl Estradiol / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008597:Menstrual Cycle; D009652:Norpregnenes / Q000008:administration & dosage; D011247:Pregnancy; D045167:Progesterone Congeners / Q000008:administration & dosage; D011446:Prospective Studies; D014592:Uterine Hemorrhage
chemical_list: D003277:Contraceptives, Oral, Combined; D045166:Estradiol Congeners; D009652:Norpregnenes; D045167:Progesterone Congeners; C033273:Gestodene; D004997:Ethinyl Estradiol; D017135:Desogestrel