Feasibility study of Nestorone®-ethinylestradiol vaginal contraceptive ring for emergency contraception

Horatio B. Croxatto, Vivian Brache, Rebecca Massai, Francisco Alvarez, M. L. Forcelledo, Margarita Pavez, Leila Cochon, Ana Maria Salvatierra, Aníbal Faundes

Resultado de la investigación: Article

17 Citas (Scopus)

Resumen

Objective: The Nestorone®/ethinylestradiol (NES/EE) vaginal ring is being developed as a regular contraceptive method by the Population Council. This ring is designed to release NES 150 μg/day and EE 15 μg/day during 1 year. Here, we report a Phase I clinical trial to determine the usefulness of this ring for emergency contraception. To that end, we tested the ability of this ring to interfere with ovulation when it is inserted during the follicular phase. Method: Forty-eight women protected from the risk of pregnancy by nonhormonal methods were divided into three groups, which differed by the size of the dominant follicle at the time of ring insertion: 12-14 mm (n=16), 15-17 mm (n=18) and ≥18 mm (n=14) diameter. The NES/EE ring was left in the vagina for 7 consecutive days, after which it was removed. The growth of the leading follicle and plasma levels of estradiol, progesterone (P), luteinizing hormone (LH) and follicle stimulating hormone (FSH) in the ensuing 5 days after ring insertion were determined. Afterwards, steroid hormones were measured twice a week, until menses took place. All women had a control cycle before the ring cycle, and the range of maximum follicular diameter assigned to each volunteer was the same for the control and the ring cycle at the time when placebo was ingested or the ring inserted. Results: During the 5-day period after ring insertion with follicles 12-17 mm, ovulation was absent in 25 of 34 cycles (p<.01 vs. control), and ovulatory dysfunction (absent, blunted or mistimed LH peak) occurred in 8 of the 9 remaining cycles (33/34 ovulatory processes altered; p<.005 vs. control). After ring insertion with follicles ≥18 mm in diameter, ovulation did not occur in 2 of 14 cycles or was dysfunctional in 7 of the 12 remaining cycles (9/14 ovulatory processes altered; p<.025 vs. control). Altogether, 87.5% of ring cycles (42/48) had either no ovulation or ovulatory dysfunction in the 5-day study period, in contrast to 39.6% (19/48 cycles) in control cycles (p<.001). Among follicles that failed to rupture within the 5-day study period, none ruptured later on in the ring-treated cycles, while 9 of 16 did so in control cycles. Sixty-two percent of ring-treated cycles were shorter than 24 days. Nausea, vaginal discharge and abdominal pain were the most frequently reported adverse events during ring use. Conclusion: Interference with 87.5% of ovulatory processes, without ovulation occurring later in the cycle and shortening of cycle length, suggests the NES/EE ring may be used as an emergency contraceptive method, with the potential advantage of providing continuing contraception after it has performed its emergency function.

Idioma originalEnglish
Páginas (desde-hasta)46-52
Número de páginas7
PublicaciónContraception
Volumen73
N.º1
DOI
EstadoPublished - 1 ene 2006

Huella dactilar

Female Contraceptive Devices
Postcoital Contraception
Ethinyl Estradiol
Feasibility Studies
Contraceptive Agents
Ovulation
Contraception
Luteinizing Hormone
Postcoital Contraceptives
Vaginal Discharge
Clinical Trials, Phase I
Follicular Phase
Menstruation
Follicle Stimulating Hormone
Vagina
Nausea
Abdominal Pain
Progesterone
Rupture
Volunteers

ASJC Scopus subject areas

  • Medicine(all)
  • Obstetrics and Gynaecology

Citar esto

Croxatto, Horatio B. ; Brache, Vivian ; Massai, Rebecca ; Alvarez, Francisco ; Forcelledo, M. L. ; Pavez, Margarita ; Cochon, Leila ; Salvatierra, Ana Maria ; Faundes, Aníbal. / Feasibility study of Nestorone®-ethinylestradiol vaginal contraceptive ring for emergency contraception. En: Contraception. 2006 ; Vol. 73, N.º 1. pp. 46-52.
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abstract = "Objective: The Nestorone{\circledR}/ethinylestradiol (NES/EE) vaginal ring is being developed as a regular contraceptive method by the Population Council. This ring is designed to release NES 150 μg/day and EE 15 μg/day during 1 year. Here, we report a Phase I clinical trial to determine the usefulness of this ring for emergency contraception. To that end, we tested the ability of this ring to interfere with ovulation when it is inserted during the follicular phase. Method: Forty-eight women protected from the risk of pregnancy by nonhormonal methods were divided into three groups, which differed by the size of the dominant follicle at the time of ring insertion: 12-14 mm (n=16), 15-17 mm (n=18) and ≥18 mm (n=14) diameter. The NES/EE ring was left in the vagina for 7 consecutive days, after which it was removed. The growth of the leading follicle and plasma levels of estradiol, progesterone (P), luteinizing hormone (LH) and follicle stimulating hormone (FSH) in the ensuing 5 days after ring insertion were determined. Afterwards, steroid hormones were measured twice a week, until menses took place. All women had a control cycle before the ring cycle, and the range of maximum follicular diameter assigned to each volunteer was the same for the control and the ring cycle at the time when placebo was ingested or the ring inserted. Results: During the 5-day period after ring insertion with follicles 12-17 mm, ovulation was absent in 25 of 34 cycles (p<.01 vs. control), and ovulatory dysfunction (absent, blunted or mistimed LH peak) occurred in 8 of the 9 remaining cycles (33/34 ovulatory processes altered; p<.005 vs. control). After ring insertion with follicles ≥18 mm in diameter, ovulation did not occur in 2 of 14 cycles or was dysfunctional in 7 of the 12 remaining cycles (9/14 ovulatory processes altered; p<.025 vs. control). Altogether, 87.5{\%} of ring cycles (42/48) had either no ovulation or ovulatory dysfunction in the 5-day study period, in contrast to 39.6{\%} (19/48 cycles) in control cycles (p<.001). Among follicles that failed to rupture within the 5-day study period, none ruptured later on in the ring-treated cycles, while 9 of 16 did so in control cycles. Sixty-two percent of ring-treated cycles were shorter than 24 days. Nausea, vaginal discharge and abdominal pain were the most frequently reported adverse events during ring use. Conclusion: Interference with 87.5{\%} of ovulatory processes, without ovulation occurring later in the cycle and shortening of cycle length, suggests the NES/EE ring may be used as an emergency contraceptive method, with the potential advantage of providing continuing contraception after it has performed its emergency function.",
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Croxatto, HB, Brache, V, Massai, R, Alvarez, F, Forcelledo, ML, Pavez, M, Cochon, L, Salvatierra, AM & Faundes, A 2006, 'Feasibility study of Nestorone®-ethinylestradiol vaginal contraceptive ring for emergency contraception', Contraception, vol. 73, n.º 1, pp. 46-52. https://doi.org/10.1016/j.contraception.2005.06.071

Feasibility study of Nestorone®-ethinylestradiol vaginal contraceptive ring for emergency contraception. / Croxatto, Horatio B.; Brache, Vivian; Massai, Rebecca; Alvarez, Francisco; Forcelledo, M. L.; Pavez, Margarita; Cochon, Leila; Salvatierra, Ana Maria; Faundes, Aníbal.

En: Contraception, Vol. 73, N.º 1, 01.01.2006, p. 46-52.

Resultado de la investigación: Article

TY - JOUR

T1 - Feasibility study of Nestorone®-ethinylestradiol vaginal contraceptive ring for emergency contraception

AU - Croxatto, Horatio B.

AU - Brache, Vivian

AU - Massai, Rebecca

AU - Alvarez, Francisco

AU - Forcelledo, M. L.

AU - Pavez, Margarita

AU - Cochon, Leila

AU - Salvatierra, Ana Maria

AU - Faundes, Aníbal

PY - 2006/1/1

Y1 - 2006/1/1

N2 - Objective: The Nestorone®/ethinylestradiol (NES/EE) vaginal ring is being developed as a regular contraceptive method by the Population Council. This ring is designed to release NES 150 μg/day and EE 15 μg/day during 1 year. Here, we report a Phase I clinical trial to determine the usefulness of this ring for emergency contraception. To that end, we tested the ability of this ring to interfere with ovulation when it is inserted during the follicular phase. Method: Forty-eight women protected from the risk of pregnancy by nonhormonal methods were divided into three groups, which differed by the size of the dominant follicle at the time of ring insertion: 12-14 mm (n=16), 15-17 mm (n=18) and ≥18 mm (n=14) diameter. The NES/EE ring was left in the vagina for 7 consecutive days, after which it was removed. The growth of the leading follicle and plasma levels of estradiol, progesterone (P), luteinizing hormone (LH) and follicle stimulating hormone (FSH) in the ensuing 5 days after ring insertion were determined. Afterwards, steroid hormones were measured twice a week, until menses took place. All women had a control cycle before the ring cycle, and the range of maximum follicular diameter assigned to each volunteer was the same for the control and the ring cycle at the time when placebo was ingested or the ring inserted. Results: During the 5-day period after ring insertion with follicles 12-17 mm, ovulation was absent in 25 of 34 cycles (p<.01 vs. control), and ovulatory dysfunction (absent, blunted or mistimed LH peak) occurred in 8 of the 9 remaining cycles (33/34 ovulatory processes altered; p<.005 vs. control). After ring insertion with follicles ≥18 mm in diameter, ovulation did not occur in 2 of 14 cycles or was dysfunctional in 7 of the 12 remaining cycles (9/14 ovulatory processes altered; p<.025 vs. control). Altogether, 87.5% of ring cycles (42/48) had either no ovulation or ovulatory dysfunction in the 5-day study period, in contrast to 39.6% (19/48 cycles) in control cycles (p<.001). Among follicles that failed to rupture within the 5-day study period, none ruptured later on in the ring-treated cycles, while 9 of 16 did so in control cycles. Sixty-two percent of ring-treated cycles were shorter than 24 days. Nausea, vaginal discharge and abdominal pain were the most frequently reported adverse events during ring use. Conclusion: Interference with 87.5% of ovulatory processes, without ovulation occurring later in the cycle and shortening of cycle length, suggests the NES/EE ring may be used as an emergency contraceptive method, with the potential advantage of providing continuing contraception after it has performed its emergency function.

AB - Objective: The Nestorone®/ethinylestradiol (NES/EE) vaginal ring is being developed as a regular contraceptive method by the Population Council. This ring is designed to release NES 150 μg/day and EE 15 μg/day during 1 year. Here, we report a Phase I clinical trial to determine the usefulness of this ring for emergency contraception. To that end, we tested the ability of this ring to interfere with ovulation when it is inserted during the follicular phase. Method: Forty-eight women protected from the risk of pregnancy by nonhormonal methods were divided into three groups, which differed by the size of the dominant follicle at the time of ring insertion: 12-14 mm (n=16), 15-17 mm (n=18) and ≥18 mm (n=14) diameter. The NES/EE ring was left in the vagina for 7 consecutive days, after which it was removed. The growth of the leading follicle and plasma levels of estradiol, progesterone (P), luteinizing hormone (LH) and follicle stimulating hormone (FSH) in the ensuing 5 days after ring insertion were determined. Afterwards, steroid hormones were measured twice a week, until menses took place. All women had a control cycle before the ring cycle, and the range of maximum follicular diameter assigned to each volunteer was the same for the control and the ring cycle at the time when placebo was ingested or the ring inserted. Results: During the 5-day period after ring insertion with follicles 12-17 mm, ovulation was absent in 25 of 34 cycles (p<.01 vs. control), and ovulatory dysfunction (absent, blunted or mistimed LH peak) occurred in 8 of the 9 remaining cycles (33/34 ovulatory processes altered; p<.005 vs. control). After ring insertion with follicles ≥18 mm in diameter, ovulation did not occur in 2 of 14 cycles or was dysfunctional in 7 of the 12 remaining cycles (9/14 ovulatory processes altered; p<.025 vs. control). Altogether, 87.5% of ring cycles (42/48) had either no ovulation or ovulatory dysfunction in the 5-day study period, in contrast to 39.6% (19/48 cycles) in control cycles (p<.001). Among follicles that failed to rupture within the 5-day study period, none ruptured later on in the ring-treated cycles, while 9 of 16 did so in control cycles. Sixty-two percent of ring-treated cycles were shorter than 24 days. Nausea, vaginal discharge and abdominal pain were the most frequently reported adverse events during ring use. Conclusion: Interference with 87.5% of ovulatory processes, without ovulation occurring later in the cycle and shortening of cycle length, suggests the NES/EE ring may be used as an emergency contraceptive method, with the potential advantage of providing continuing contraception after it has performed its emergency function.

KW - Emergency contraception

KW - Ethinylestradiol

KW - Nestorone®

KW - Ovulatory dysfunction

KW - Vaginal ring

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