Extended use of a progesterone-releasing vaginal ring in nursing women: A phase II clinical trial

Rebeca Massai, Eliana Quinteros, María Verónica Reyes, Roxana Caviedes, Ana Zepeda, Juan Carlos Montero, Horacio B. Croxatto

Resultado de la investigación: Article

19 Citas (Scopus)

Resumen

Aim: This study evaluates the performance of extended use of a progesterone (P)-releasing vaginal ring (PVR) in nursing women. Method: An open-label, noncomparative study on the safety and contraceptive efficacy of PVR replaced every 4 months of use (instead of 3 months) in 192 PVR acceptors. PVR use was initiated at day 59±2 (mean±SD) postpartum and continued until weaning or completing the use of three PVRs. Results: Plasma P levels attained with the ring decreased from 17±1 to 14±1 nmol/L (mean±SE) from the third to the fourth month of use. These levels are still over the critical level of 10 nmol/L required for contraceptive protection. One pregnancy occurred in the third month of use of the second ring in 1998 woman-months of exposure. Extended use of the ring did not appear to affect breast-feeding performance or the rate of infant growth, and lactational amenorrhea was prolonged. No differences in the characteristics of bleeding between the third and fourth month of ring use were observed. Conclusion: The results indicate that use of the PVR for 4 months represents a safe and effective contraceptive for nursing women.

Idioma originalEnglish
Páginas (desde-hasta)352-357
Número de páginas6
PublicaciónContraception
Volumen72
N.º5
DOI
EstadoPublished - 1 nov 2005

Huella dactilar

Female Contraceptive Devices
Phase II Clinical Trials
Progesterone
Nursing
Contraceptive Agents
Amenorrhea
Weaning
Breast Feeding
Postpartum Period
Hemorrhage
Safety
Pregnancy
Growth

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynaecology

Citar esto

Massai, Rebeca ; Quinteros, Eliana ; Reyes, María Verónica ; Caviedes, Roxana ; Zepeda, Ana ; Montero, Juan Carlos ; Croxatto, Horacio B. / Extended use of a progesterone-releasing vaginal ring in nursing women : A phase II clinical trial. En: Contraception. 2005 ; Vol. 72, N.º 5. pp. 352-357.
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Extended use of a progesterone-releasing vaginal ring in nursing women : A phase II clinical trial. / Massai, Rebeca; Quinteros, Eliana; Reyes, María Verónica; Caviedes, Roxana; Zepeda, Ana; Montero, Juan Carlos; Croxatto, Horacio B.

En: Contraception, Vol. 72, N.º 5, 01.11.2005, p. 352-357.

Resultado de la investigación: Article

TY - JOUR

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T2 - A phase II clinical trial

AU - Massai, Rebeca

AU - Quinteros, Eliana

AU - Reyes, María Verónica

AU - Caviedes, Roxana

AU - Zepeda, Ana

AU - Montero, Juan Carlos

AU - Croxatto, Horacio B.

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N2 - Aim: This study evaluates the performance of extended use of a progesterone (P)-releasing vaginal ring (PVR) in nursing women. Method: An open-label, noncomparative study on the safety and contraceptive efficacy of PVR replaced every 4 months of use (instead of 3 months) in 192 PVR acceptors. PVR use was initiated at day 59±2 (mean±SD) postpartum and continued until weaning or completing the use of three PVRs. Results: Plasma P levels attained with the ring decreased from 17±1 to 14±1 nmol/L (mean±SE) from the third to the fourth month of use. These levels are still over the critical level of 10 nmol/L required for contraceptive protection. One pregnancy occurred in the third month of use of the second ring in 1998 woman-months of exposure. Extended use of the ring did not appear to affect breast-feeding performance or the rate of infant growth, and lactational amenorrhea was prolonged. No differences in the characteristics of bleeding between the third and fourth month of ring use were observed. Conclusion: The results indicate that use of the PVR for 4 months represents a safe and effective contraceptive for nursing women.

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