Preregistration study on the safety and contraceptive efficacy of a progesterone-releasing vaginal ring in Chilean nursing women.

Massai, R; Miranda, P; Valdés, P; Lavín, P; Zepeda, A; Casado, M E; Silva, M A; Fetis, G; Bravo, C; Chandía, O; Peralta, O; Croxatto, H B; Díaz, S

Massai, R; Miranda, P; Valdés, P; Lavín, P; Zepeda, A; Casado, M E; Silva, M A; Fetis, G; Bravo, C; Chandía, O; Peralta, O; Croxatto, H B; Díaz, S.

Afiliação

Massai R; Instituto Chileno de Medicina Reproductiva, Consultorio de Planificación Familiar, Santiago, Chile.

Contraception ; 60(1): 9-14, 1999 Jul.

Article em En | MEDLINE | ID: mdl-10549447

ABSTRACT

ABSTRACT

PIP: This study compares the contraceptive efficacy and safety of a progesterone-releasing vaginal ring (PVR) manufactured in Chile and a Copper T 380A IUD (T-Cu) in nursing women enrolled at three Chilean clinics. A total of 285 volunteers used the PVR and 262 used T-Cu. Plasma progesterone levels attained with the ring decreased from 25 to 14 nmol/l from month 1 to month 3 of use. Ring replacement was scheduled every 3 months. Volunteers continued in the study until weaning or completing the continuous use of 4 PVRs. There were no pregnancies in 2320 and 2183 woman-months of exposure with the PVR and the T-Cu, respectively. Lower continuation rates in the first 6 months because of problems with use and a longer lactational amenorrhea were seen in the PVR group. Breast-feeding performance and infant growth were similar in both groups. These results prove the high efficacy and safety of the PVR for nursing women. This has led to the registration of the PVR by Chilean health authorities.

Assuntos

Aleitamento Materno; Dispositivos Anticoncepcionais Femininos/normas; Leite Humano/efeitos dos fármacos; Progesterona/farmacocinética; Adulto; Amenorreia/induzido quimicamente; Peso ao Nascer; Peso Corporal; Chile; Colposcopia; Dispositivos Anticoncepcionais Femininos/efeitos adversos; Feminino; Hemoglobinas/análise; Humanos; Lactente; Dispositivos Intrauterinos de Cobre/efeitos adversos; Dispositivos Intrauterinos de Cobre/normas; Lactação; Masculino; Paridade; Pacientes Desistentes do Tratamento; Satisfação do Paciente; Progesterona/sangue; Progesterona/farmacologia; Radioimunoensaio; Vagina/efeitos dos fármacos

Palavras-chave

Americas; Biology; Chile; Contraception; Contraceptive Agents; Contraceptive Agents, Female; Contraceptive Agents, Progestin; Contraceptive Effectiveness; Contraceptive Methods; Developing Countries; Endocrine System; Family Planning; Hormones; Iud; Iud, Copper Releasing; Latin America; Physiology; Progestational Hormones; Progesterone; Research Report; South America; Vaginal Rings

Buscar no Google

Adicionar na Minha BVS

Imprimir

XML

PubMed Links

Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Progesterona / Aleitamento Materno / Dispositivos Anticoncepcionais Femininos / Leite Humano Tipo de estudo: Clinical_trials Limite: Adult / Female / Humans / Infant / Male País/Região como assunto: America do sul / Chile Idioma: En Revista: Contraception Ano de publicação: 1999 Tipo de documento: Article País de afiliação: Chile País de publicação: Estados Unidos

Buscar no Google

Adicionar na Minha BVS

Imprimir

XML

PubMed Links