Multicenter, double-blind, comparative clinical study on the efficacy and 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 mg dihydroxyprogesterone acetophenide with 6 mg estradiol enanthate compared to the commercially available contraceptive combination of 150 mg dihydroxyprogesterone acetophenide with 10 mg estradiol enanthate. Subjects received the contraceptive combination intramuscularly, between the 7th and 10th day of each menstrual cycle, during 12 consecutive menstrual cycles. Approximately 60% of the subjects in both groups completed the study. Principal reasons for discontinuation were personal, nonmedical reasons. Principal medical reasons for discontinuation were menstrual-related, irregular bleeding being the most frequent. Differences in menstrual patterns between the two groups did not lead to differences in discontinuation rates. Three contraceptive failures occurred 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 efficient as the higher dose.
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Centro de Pesquisas e Assistencia em Reprodução Humana-CePARH, Salvador, Bahia, Brazil.
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Barbosa
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Gatto
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Tomaz
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Morais
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Yazlle
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de Souza
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Pinho Neto
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Hippolito
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D000293:Adolescent; D000328:Adult; D000463:Algestone Acetophenide / Q000008:administration & dosage / Q000009:adverse effects*; D001835:Body Weight; D001938:Brazil; D015331:Cohort Studies; D003270:Contraceptive Agents / Q000008:administration & dosage / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D015994:Incidence; D008598:Menstruation / Q000187:drug effects* / Q000502:physiology; D010342:Patient Acceptance of Health Care; D010352:Patient Dropouts / Q000706:statistics & numerical data; D045167:Progesterone Congeners / Q000008:administration & dosage / Q000009:adverse effects*; D014592:Uterine Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology
D003270:Contraceptive Agents; D045167:Progesterone Congeners; D004958:Estradiol; D000463:Algestone Acetophenide; C002027:estradiol enanthate