A multicenter clinical evaluation of a new monophasic combination: Minulet (gestodene and ethinyl estradiol).
The safety and efficacy of a low-dose monophasic oral contraceptive (OC) containing a new progestogen, gestodene (GTD), combined with ethinyl estradiol (EE) is being investigated in two ongoing multicenter trails. In this interim analysis, the formulation was found to be effective and well tolerated. Subject compliance was excellent; no pills were missed in 91.2% of the cycles. The number of women who withdrew from the study was low (15%), indicating good subject acceptance. GTD + EE provided optimal cycle control. Of the total number of OC cycles analyzed, spotting occurred in 8.1%, breakthrough bleeding in 1.8%, and both spotting and breakthrough bleeding in 3.3%. The incidence of spotting decreased fairly steadily during OC administration. Amenorrhea occurred in 0.5% of the cycles. There were no unexpected or serious side effects. The incidence of side effects was low and declined with increased duration of OC use. There were no clinically significant changes in weight or blood pressure. Virtually all of the systolic and diastolic blood pressure readings were in the normal range. The results of this interim analysis indicate that the GTD + EE formulation is a safe and reliable contraceptive.
de Andrade
R P
RP
Hospital de Clinicas de U.F.P. Curitiba, Brazil.
D000293:Adolescent; D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D001940:Breast / Q000187:drug effects; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects / Q000494:pharmacology; D004997:Ethinyl Estradiol / Q000009:adverse effects / Q000494:pharmacology*; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects*; D008968:Molecular Conformation; D015394:Molecular Structure; D015337:Multicenter Studies as Topic; D009325:Nausea / Q000139:chemically induced; D009652:Norpregnenes / Q000009:adverse effects / Q000494:pharmacology*; D010349:Patient Compliance; D013020:South America
D003277:Contraceptives, Oral, Combined; D009652:Norpregnenes; C055368:Femovan; D004997:Ethinyl Estradiol