MULTICENTER, DOUBLE-BLIND, COMPARATIVE CLINICAL-STUDY ON THE EFFICACYAND ACCEPTABILITY OF A MONTHLY INJECTABLE CONTRACEPTIVE COMBINATION OF 150-MG DIHYDROXYPROGESTERONE ACETOPHENIDE AND 10-MG ESTRADIOL ENANTHATE COMPARED TO A MONTHLY INJECTABLE CONTRACEPTIVE COMBINATION OF 90-MG DIHYDROXYPROGESTERONE ACETOPHENIDE AND 6-MG ESTRADIOL ENANTHATE

Healthy, regularly menstruating women, aged 14-38 years, were enrolled in a comparative, double-blind, phase III, clinical trial to evaluate the contraceptive efficacy and acceptability of a combination of 90 m g dihydroxyprogesterone acetophenide with 6 mg estradiol enanthate com pared to the commercially available contraceptive combination of 150 m g dihydroxyprogesterone acetophenide with 10 mg estradiol enanthate. S ubjects received the contraceptive combination intramuscularly, betwee n the 7th and 10th day of each menstrual cycle, during 12 consecutive menstrual cycles. Approximately 60% of the subjects in both groups com pleted the study. Principal reasons for discontinuation were personal, nonmedical reasons. Principal medical reasons for discontinuation wer e menstrual-related, irregular bleeding being the most frequent. Diffe rences in menstrual patterns between the two groups did not lead to di fferences in discontinuation rates. Three contraceptive failures occur red during the trial, one in Group A (90/6 mg) and two in Group B (150 /10 mg), indicating that the lower dose formulation is at least as eff icient as the higher dose, (C) 1997 Elsevier Science Inc.