Clinical trial with Nestorone subdermal contraceptive implants

S. Díaz, V. Schiappacasse, M. Pavez, A. Zepeda, A. J. Moo-Young, A. Brandeis, P. Lähteenmäki, H. B. Croxatto

Resultado de la investigación: Article

41 Citas (Scopus)

Resumen

The clinical performance and the in vivo release rate of a single 4-cm Nestorone™1 1 Nestorone is the Population Council trademark for 16-methylene-17-alpha-acetoxy-19 norprogesterone, previously known as ST 1435. subdermal implant were investigated. Implants manufactured by two different procedures were compared. Volunteers were 70 healthy women of proven fertility. Forty women provided blood samples twice a week in the pretreatment cycle and for 5-6 weeks at 6-month intervals during treatment. Additional control cycles (n = 31) were studied in 19 Copper T users. No pregnancy occurred in 1570 woman-months. Nesterone plasma levels (X ± S.E.) declined from 112 ± 8 to 86 ± 3 pmol/L (Implant A) and from 145 ± 8 to 57 ± 5 pmol/L (Implant B) from the first to the 24th month. Progesterone levels were <9.5 nmol/L in 166 (93%) of 178 blood samplings taken during treatment. Progesterone levels >16 nmol/L were found in only 7 sampling periods (3.9%) in treated women and in 70 (98.6%) out of 71 control cycles. No ovulation occurred with Nestorone plasma levels above 105 pmol/L. No abnormal changes were observed in plasma lipoproteins or other clinical chemistry parameters during treatment. The implants were well tolerated. The most frequent complaint was the occurrence of irregular bleeding. Enlarged follicles found during pelvic examination in 8 subjects (11.4%) disappeared spontaneously in 10 days to 6 weeks. Implants were removed because of medical (n = 10, 14.3%) or personal reasons (n = 6, 8.6%) or at the 24th month of treatment (n = 54, 77.1%). The estimated average daily in vivo release rate of Nestorone was 45-50 μg/day. A single Nestorone subdermal implant affords efficient contraceptive protection during two years.

Idioma originalEnglish
Páginas (desde-hasta)33-38
Número de páginas6
PublicaciónContraception
Volumen51
N.º1
DOI
EstadoPublished - 1 ene 1995

Huella dactilar

Contraceptive Agents
Clinical Trials
Gynecological Examination
Clinical Chemistry
Patents
Ovulation
Lipoproteins
Progesterone
Fertility
Copper
Volunteers
Therapeutics
ST 1435
Hemorrhage
Pregnancy
Population

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynaecology

Citar esto

Díaz, S., Schiappacasse, V., Pavez, M., Zepeda, A., Moo-Young, A. J., Brandeis, A., ... Croxatto, H. B. (1995). Clinical trial with Nestorone subdermal contraceptive implants. Contraception, 51(1), 33-38. https://doi.org/10.1016/0010-7824(94)00006-I
Díaz, S. ; Schiappacasse, V. ; Pavez, M. ; Zepeda, A. ; Moo-Young, A. J. ; Brandeis, A. ; Lähteenmäki, P. ; Croxatto, H. B. / Clinical trial with Nestorone subdermal contraceptive implants. En: Contraception. 1995 ; Vol. 51, N.º 1. pp. 33-38.
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abstract = "The clinical performance and the in vivo release rate of a single 4-cm Nestorone™1 1 Nestorone™ is the Population Council trademark for 16-methylene-17-alpha-acetoxy-19 norprogesterone, previously known as ST 1435. subdermal implant were investigated. Implants manufactured by two different procedures were compared. Volunteers were 70 healthy women of proven fertility. Forty women provided blood samples twice a week in the pretreatment cycle and for 5-6 weeks at 6-month intervals during treatment. Additional control cycles (n = 31) were studied in 19 Copper T users. No pregnancy occurred in 1570 woman-months. Nesterone™ plasma levels (X ± S.E.) declined from 112 ± 8 to 86 ± 3 pmol/L (Implant A) and from 145 ± 8 to 57 ± 5 pmol/L (Implant B) from the first to the 24th month. Progesterone levels were <9.5 nmol/L in 166 (93{\%}) of 178 blood samplings taken during treatment. Progesterone levels >16 nmol/L were found in only 7 sampling periods (3.9{\%}) in treated women and in 70 (98.6{\%}) out of 71 control cycles. No ovulation occurred with Nestorone™ plasma levels above 105 pmol/L. No abnormal changes were observed in plasma lipoproteins or other clinical chemistry parameters during treatment. The implants were well tolerated. The most frequent complaint was the occurrence of irregular bleeding. Enlarged follicles found during pelvic examination in 8 subjects (11.4{\%}) disappeared spontaneously in 10 days to 6 weeks. Implants were removed because of medical (n = 10, 14.3{\%}) or personal reasons (n = 6, 8.6{\%}) or at the 24th month of treatment (n = 54, 77.1{\%}). The estimated average daily in vivo release rate of Nestorone™ was 45-50 μg/day. A single Nestorone™ subdermal implant affords efficient contraceptive protection during two years.",
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Díaz, S, Schiappacasse, V, Pavez, M, Zepeda, A, Moo-Young, AJ, Brandeis, A, Lähteenmäki, P & Croxatto, HB 1995, 'Clinical trial with Nestorone subdermal contraceptive implants', Contraception, vol. 51, n.º 1, pp. 33-38. https://doi.org/10.1016/0010-7824(94)00006-I

Clinical trial with Nestorone subdermal contraceptive implants. / Díaz, S.; Schiappacasse, V.; Pavez, M.; Zepeda, A.; Moo-Young, A. J.; Brandeis, A.; Lähteenmäki, P.; Croxatto, H. B.

En: Contraception, Vol. 51, N.º 1, 01.01.1995, p. 33-38.

Resultado de la investigación: Article

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T1 - Clinical trial with Nestorone™ subdermal contraceptive implants

AU - Díaz, S.

AU - Schiappacasse, V.

AU - Pavez, M.

AU - Zepeda, A.

AU - Moo-Young, A. J.

AU - Brandeis, A.

AU - Lähteenmäki, P.

AU - Croxatto, H. B.

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N2 - The clinical performance and the in vivo release rate of a single 4-cm Nestorone™1 1 Nestorone™ is the Population Council trademark for 16-methylene-17-alpha-acetoxy-19 norprogesterone, previously known as ST 1435. subdermal implant were investigated. Implants manufactured by two different procedures were compared. Volunteers were 70 healthy women of proven fertility. Forty women provided blood samples twice a week in the pretreatment cycle and for 5-6 weeks at 6-month intervals during treatment. Additional control cycles (n = 31) were studied in 19 Copper T users. No pregnancy occurred in 1570 woman-months. Nesterone™ plasma levels (X ± S.E.) declined from 112 ± 8 to 86 ± 3 pmol/L (Implant A) and from 145 ± 8 to 57 ± 5 pmol/L (Implant B) from the first to the 24th month. Progesterone levels were <9.5 nmol/L in 166 (93%) of 178 blood samplings taken during treatment. Progesterone levels >16 nmol/L were found in only 7 sampling periods (3.9%) in treated women and in 70 (98.6%) out of 71 control cycles. No ovulation occurred with Nestorone™ plasma levels above 105 pmol/L. No abnormal changes were observed in plasma lipoproteins or other clinical chemistry parameters during treatment. The implants were well tolerated. The most frequent complaint was the occurrence of irregular bleeding. Enlarged follicles found during pelvic examination in 8 subjects (11.4%) disappeared spontaneously in 10 days to 6 weeks. Implants were removed because of medical (n = 10, 14.3%) or personal reasons (n = 6, 8.6%) or at the 24th month of treatment (n = 54, 77.1%). The estimated average daily in vivo release rate of Nestorone™ was 45-50 μg/day. A single Nestorone™ subdermal implant affords efficient contraceptive protection during two years.

AB - The clinical performance and the in vivo release rate of a single 4-cm Nestorone™1 1 Nestorone™ is the Population Council trademark for 16-methylene-17-alpha-acetoxy-19 norprogesterone, previously known as ST 1435. subdermal implant were investigated. Implants manufactured by two different procedures were compared. Volunteers were 70 healthy women of proven fertility. Forty women provided blood samples twice a week in the pretreatment cycle and for 5-6 weeks at 6-month intervals during treatment. Additional control cycles (n = 31) were studied in 19 Copper T users. No pregnancy occurred in 1570 woman-months. Nesterone™ plasma levels (X ± S.E.) declined from 112 ± 8 to 86 ± 3 pmol/L (Implant A) and from 145 ± 8 to 57 ± 5 pmol/L (Implant B) from the first to the 24th month. Progesterone levels were <9.5 nmol/L in 166 (93%) of 178 blood samplings taken during treatment. Progesterone levels >16 nmol/L were found in only 7 sampling periods (3.9%) in treated women and in 70 (98.6%) out of 71 control cycles. No ovulation occurred with Nestorone™ plasma levels above 105 pmol/L. No abnormal changes were observed in plasma lipoproteins or other clinical chemistry parameters during treatment. The implants were well tolerated. The most frequent complaint was the occurrence of irregular bleeding. Enlarged follicles found during pelvic examination in 8 subjects (11.4%) disappeared spontaneously in 10 days to 6 weeks. Implants were removed because of medical (n = 10, 14.3%) or personal reasons (n = 6, 8.6%) or at the 24th month of treatment (n = 54, 77.1%). The estimated average daily in vivo release rate of Nestorone™ was 45-50 μg/day. A single Nestorone™ subdermal implant affords efficient contraceptive protection during two years.

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KW - progestin

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Díaz S, Schiappacasse V, Pavez M, Zepeda A, Moo-Young AJ, Brandeis A y otros. Clinical trial with Nestorone subdermal contraceptive implants. Contraception. 1995 ene 1;51(1):33-38. https://doi.org/10.1016/0010-7824(94)00006-I