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

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

Resultado de la investigación: Article

43 Citas (Scopus)

Resumen

The contraceptive efficacy and safety of a progesterone-releasing vaginal ring (PVR) manufactured in Chile were compared to that of the Copper T 380A IUD (T-Cu) in nursing women enrolled at three Chilean clinics. A total of 285 volunteers chose to use the PVR and 262 the 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 four PVRs. No pregnancies occurred 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 observed in the PVR than in the T-Cu group. Breast-feeding performance and infant growth were similar in both groups. These results confirm the high efficacy and safety of the PVR for nursing women and have led to the registration of the PVR by Chilean health authorities.

Idioma originalEnglish
Páginas (desde-hasta)9-14
Número de páginas6
PublicaciónContraception
Volumen60
N.º1
DOI
EstadoPublished - 1 jul 1999

Huella dactilar

Female Contraceptive Devices
Contraceptive Agents
Progesterone
Nursing
Safety
Volunteers
Chile
Amenorrhea
Weaning
Breast Feeding
Copper
Pregnancy
Health
Growth

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynaecology

Citar esto

Massai, Rebeca ; 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. / Preregistration study on the safety and contraceptive efficacy of a progesterone-releasing vaginal ring in Chilean nursing women. En: Contraception. 1999 ; Vol. 60, N.º 1. pp. 9-14.
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abstract = "The contraceptive efficacy and safety of a progesterone-releasing vaginal ring (PVR) manufactured in Chile were compared to that of the Copper T 380A IUD (T-Cu) in nursing women enrolled at three Chilean clinics. A total of 285 volunteers chose to use the PVR and 262 the 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 four PVRs. No pregnancies occurred 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 observed in the PVR than in the T-Cu group. Breast-feeding performance and infant growth were similar in both groups. These results confirm the high efficacy and safety of the PVR for nursing women and have led to the registration of the PVR by Chilean health authorities.",
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Massai, R, Miranda, P, Valdés, P, Lavín, P, Zepeda, A, Casado, ME, Silva, MA, Fetis, G, Bravo, C, Chandía, O, Peralta, O, Croxatto, HB & Díaz, S 1999, 'Preregistration study on the safety and contraceptive efficacy of a progesterone-releasing vaginal ring in Chilean nursing women', Contraception, vol. 60, n.º 1, pp. 9-14. https://doi.org/10.1016/S0010-7824(99)00057-8

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

En: Contraception, Vol. 60, N.º 1, 01.07.1999, p. 9-14.

Resultado de la investigación: Article

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AU - Valdés, P.

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AU - Zepeda, A.

AU - Casado, M. E.

AU - Silva, M. A.

AU - Fetis, G.

AU - Bravo, C.

AU - Chandía, O.

AU - Peralta, O.

AU - Croxatto, H. B.

AU - Díaz, S.

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N2 - The contraceptive efficacy and safety of a progesterone-releasing vaginal ring (PVR) manufactured in Chile were compared to that of the Copper T 380A IUD (T-Cu) in nursing women enrolled at three Chilean clinics. A total of 285 volunteers chose to use the PVR and 262 the 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 four PVRs. No pregnancies occurred 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 observed in the PVR than in the T-Cu group. Breast-feeding performance and infant growth were similar in both groups. These results confirm the high efficacy and safety of the PVR for nursing women and have led to the registration of the PVR by Chilean health authorities.

AB - The contraceptive efficacy and safety of a progesterone-releasing vaginal ring (PVR) manufactured in Chile were compared to that of the Copper T 380A IUD (T-Cu) in nursing women enrolled at three Chilean clinics. A total of 285 volunteers chose to use the PVR and 262 the 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 four PVRs. No pregnancies occurred 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 observed in the PVR than in the T-Cu group. Breast-feeding performance and infant growth were similar in both groups. These results confirm the high efficacy and safety of the PVR for nursing women and have led to the registration of the PVR by Chilean health authorities.

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KW - Copper-T IUD

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KW - Progesterone vaginal ring

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