RESUMO
A comparative clinical trial of two combined oral contraceptives differing only in estrogen type and dosage was conducted at the Centro de Investigaciones Hideyo Noguchi in Merida, Yucatan, Mexico. The trial was designed to determine the differences between Norinyl 1 + 50 (Syntex) and Norinyl 1 + 35 (Syntex) in rates of discontinuation and frequency of selected side-effects which might contribute to method discontinuation. Three hundred women were randomly assigned to either the Norinyl 1 + 35 group or to the Norinyl 1 + 50 group and follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. In the Norinyl 1 + 35 group, more women experienced an increase in intermenstrual bleeding (primarily staining and spotting) (p less than 0.05), breast discomfort (p less than 0.05) and nausea than in the Norinyl 1 + 50 group. There was a significantly higher discontinuation rate for personal reasons, such as desired change of method and method not needed, among the women taking Norinyl 1 + 35 (p less than 0.05). The largest number of discontinuations comprised women discontinuing for menstrual problems in both groups. The life-table total discontinuation rate at 12 months was 52.0 for the Norinyl 1 + 35 group and 50.7 for the Norinyl 1 + 50 group. The lost-to-follow-up rates at 12 months were 17.8 for the Norinyl 1 + 35 group and 22.8 for the Norinyl 1 + 50 group.
Assuntos
Anticoncepcionais Orais Combinados/efeitos adversos , Anticoncepcionais Orais Sintéticos/efeitos adversos , Mestranol/efeitos adversos , Noretindrona/efeitos adversos , Adolescente , Adulto , Anticoncepcionais Orais Combinados/administração & dosagem , Anticoncepcionais Orais Sintéticos/administração & dosagem , Combinação de Medicamentos , Feminino , Humanos , Mastite/induzido quimicamente , Mestranol/administração & dosagem , México , Estudos Multicêntricos como Assunto , Náusea/induzido quimicamente , Noretindrona/administração & dosagem , Cooperação do Paciente , Distribuição Aleatória , Hemorragia Uterina/induzido quimicamenteRESUMO
A comparative clinical trial of two combined oral contraceptives (OCs) with equivalent estrogen content, but different amounts of progestogens, was conducted at the Centro Medico Especializado em Planejamento Familiar in Rio Clara, Brazil. The study was designed to determine the differences in discontinuation rates between Norinyl 1/35 (Syntex) and Brevicon (Syntex) as well as the frequency of selected side effects which might contribute to method discontinuation. Both OCs contain 0.035 mg of ethinyl estradiol; Brevicon contains 0.5 mg and Norinyl 1/35 contains 1 mg norethindrone. Three-hundred women enrolled in the study were randomly assigned to either the Norinyl 1/35 or Brevicon OCs and follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Intermenstrual bleeding was reported by significantly more women in the Brevicon group than in the Norinyl group (p less than 0.05), and significantly more Brevicon users reported an increase in intermenstrual bleeding. At the end of the study period, no differences were found between the two OC groups in terms of discontinuation rates, but a large number of women in each group discontinued for menstrual problems. The total discontinuation rates at 11 months for both groups were extremely high: 68.2 for the Norinyl 1/35 group and 75.2 for the Brevicon users. The largest group of discontinuations were comprised of those discontinuing for menstrual problems, other personal reasons, planned pregnancy and side effects.
Assuntos
Anticoncepcionais Orais Hormonais , Etinilestradiol , Mestranol , Noretindrona , Adulto , Ensaios Clínicos como Assunto , Anticoncepcionais Orais Combinados/efeitos adversos , Anticoncepcionais Orais Hormonais/efeitos adversos , Combinação de Medicamentos , Etinilestradiol/efeitos adversos , Feminino , Humanos , Mestranol/efeitos adversos , Noretindrona/efeitos adversos , Fatores SocioeconômicosRESUMO
A comparative study of Norinyl 1/35 and Brevicon was conducted at the APLAFA clinic in Panama City, Panama. The study sought to evaluate the differences in continuation rates and the frequency of selected side effects which might contribute to method discontinuation. The 300 subjects were randomly allocated to one of the two oral contraceptives. Women in the Brevicon group reported significantly more (p less than 0.05) intermenstrual bleeding, nausea, headaches, dizziness and vaginal discharge than women in the Norinyl 1/35 group. The total discontinuation rate at 12 months was 28.0 for the Norinyl 1/35 group and 46.7 for the Brevicon group, and this difference was significant (p less than .01). Also, significantly more women (p less than .01) in the Brevicon group discontinued for menstrual problems than women in the Norinyl 1/35 group. No pregnancies were reported during this study. While both oral contraceptives appear safe and effective, Norinyl 1/35 was more acceptable to this group of Panamanian women.