A multicentred, two-year, phase III clinical trial of norethisterone enanthate 50 mg plus estradiol valerate 5 mg as a monthly injectable contraceptive.
Norethisterone enanthate (NET-EN) 50 mg combined with estradiol valerate (EV) 5 mg was studied as a once-a-month injectable contraceptive with regard to effectiveness, cycle control, adverse events and acceptability. In eight Family Planning Centres from 5 Latin American countries, 652 fertile women were followed-up for a period of 24 months, providing a total of 10,689 woman-months of experience. Only 1 pregnancy occurred, in the first treated month a few days before the second injection (failure rate 0.11 per 100 woman-years). Under treatment, the first cycle was drastically shortened in most cases, but thereafter cycles tended to recover to pre-treatment patterns. There was a significant decrease of hypermenorrhea and dysmenorrheic cycles. Intracyclic bleeding and spotting appeared in 1.2% and 2.4%, respectively, and amenorrhea in 2.5% of cycles. Incidence of other adverse events was very low with the exception of weight gain of 2 Kg (28%). Continuation rate at 12 months was 64.7%. The cumulative discontinuation rate due to bleeding problems was 7.4% and 10.7% due to adverse events at 24 months.
von Kesserü
E
E
First Gynecological Clinic, University of Buenos Aires, Argentina.
Aydinlik
S
S
Etchepareborda
J J
JJ
Kaufmann
J
J
D000293:Adolescent; D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards*; D003280:Contraceptives, Oral, Synthetic / Q000009:adverse effects / Q000592:standards*; D004359:Drug Therapy, Combination; D004412:Dysmenorrhea / Q000453:epidemiology; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000592:standards; D005193:Family Planning Services / Q000379:methods; D005260:Female; D006801:Humans; D015994:Incidence; D007267:Injections; D008595:Menorrhagia / Q000453:epidemiology; D008597:Menstrual Cycle / Q000187:drug effects / Q000502:physiology; D009640:Norethindrone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000592:standards; D013997:Time Factors
D003271:Contraceptive Agents, Female; D003280:Contraceptives, Oral, Synthetic; D004958:Estradiol; C024319:norethindrone enanthate; D009640:Norethindrone