Multicenter clinical trial of implanted norethindrone pellets for long-acting contraception in women

for Applied Research on Fertility Regulation Program for Applied Research on Fertility Regulation, Gopi N. Gupta, Robert Landesman, Brij B. Saxena, Mukul Singh, Ricardo H. Asch, Horacio B. Croxatto, Soledad Diaz, Margarita Pavez, Elsimar M. Coutinho, Roberto Rivera, Alfredo Goldsmith

Resultado de la investigación: Article

6 Citas (Scopus)

Resumen

Long-acting, biodegradable, subcutaneous implants of fused pellets composed of norethindrone (NET) and pure cholestrol were evaluated in 50 healthy, normally menstruating volunteers from five clinics. Evaluation of serum NET levels indicated a steady release rate over the 6-cycle follow-up period. There were no serious local reactions to the pellets. Menstrual cycle length remained unchanged, but the incidence of intermenstrual bleeding and/or spotting was higher during the initial 2-3 months of pellet use. Following pellet removal menstrual cycle parameters returned to their pre-pellet implantation values. Serum gonadotropin assays indicated the incidence of ovulatory cycles increased over the follow-up period. No significant changes in serum lipoproteins, SMAC-12 or enzyme profiles were observed. Although women were advised to use additional methods of contraception, three became pregnant while using the implants. Fibrous tissue was noted to form around the pellets, thus limiting the release of NET. Additional trials of higher NET doses are being evaluated.

Idioma originalEnglish
Páginas (desde-hasta)239-252
Número de páginas14
PublicaciónContraception
Volumen30
N.º3
DOI
EstadoPublished - 1 ene 1984

Huella dactilar

Norethindrone
Contraception
Multicenter Studies
Clinical Trials
Metrorrhagia
Menstrual Cycle
Absorbable Implants
Serum
Incidence
Gonadotropins
Lipoproteins
Volunteers
Enzymes

ASJC Scopus subject areas

  • Medicine(all)
  • Obstetrics and Gynaecology

Citar esto

Program for Applied Research on Fertility Regulation, F. A. R. O. F. R., N. Gupta, G., Landesman, R., Saxena, B. B., Singh, M., Asch, R. H., ... Goldsmith, A. (1984). Multicenter clinical trial of implanted norethindrone pellets for long-acting contraception in women. Contraception, 30(3), 239-252. https://doi.org/10.1016/0010-7824(84)90087-8
Program for Applied Research on Fertility Regulation, for Applied Research on Fertility Regulation ; N. Gupta, Gopi ; Landesman, Robert ; Saxena, Brij B. ; Singh, Mukul ; Asch, Ricardo H. ; Croxatto, Horacio B. ; Diaz, Soledad ; Pavez, Margarita ; Coutinho, Elsimar M. ; Rivera, Roberto ; Goldsmith, Alfredo. / Multicenter clinical trial of implanted norethindrone pellets for long-acting contraception in women. En: Contraception. 1984 ; Vol. 30, N.º 3. pp. 239-252.
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abstract = "Long-acting, biodegradable, subcutaneous implants of fused pellets composed of norethindrone (NET) and pure cholestrol were evaluated in 50 healthy, normally menstruating volunteers from five clinics. Evaluation of serum NET levels indicated a steady release rate over the 6-cycle follow-up period. There were no serious local reactions to the pellets. Menstrual cycle length remained unchanged, but the incidence of intermenstrual bleeding and/or spotting was higher during the initial 2-3 months of pellet use. Following pellet removal menstrual cycle parameters returned to their pre-pellet implantation values. Serum gonadotropin assays indicated the incidence of ovulatory cycles increased over the follow-up period. No significant changes in serum lipoproteins, SMAC-12 or enzyme profiles were observed. Although women were advised to use additional methods of contraception, three became pregnant while using the implants. Fibrous tissue was noted to form around the pellets, thus limiting the release of NET. Additional trials of higher NET doses are being evaluated.",
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Program for Applied Research on Fertility Regulation, FAROFR, N. Gupta, G, Landesman, R, Saxena, BB, Singh, M, Asch, RH, Croxatto, HB, Diaz, S, Pavez, M, Coutinho, EM, Rivera, R & Goldsmith, A 1984, 'Multicenter clinical trial of implanted norethindrone pellets for long-acting contraception in women', Contraception, vol. 30, n.º 3, pp. 239-252. https://doi.org/10.1016/0010-7824(84)90087-8

Multicenter clinical trial of implanted norethindrone pellets for long-acting contraception in women. / Program for Applied Research on Fertility Regulation, for Applied Research on Fertility Regulation; N. Gupta, Gopi; Landesman, Robert; Saxena, Brij B.; Singh, Mukul; Asch, Ricardo H.; Croxatto, Horacio B.; Diaz, Soledad; Pavez, Margarita; Coutinho, Elsimar M.; Rivera, Roberto; Goldsmith, Alfredo.

En: Contraception, Vol. 30, N.º 3, 01.01.1984, p. 239-252.

Resultado de la investigación: Article

TY - JOUR

T1 - Multicenter clinical trial of implanted norethindrone pellets for long-acting contraception in women

AU - Program for Applied Research on Fertility Regulation, for Applied Research on Fertility Regulation

AU - N. Gupta, Gopi

AU - Landesman, Robert

AU - Saxena, Brij B.

AU - Singh, Mukul

AU - Asch, Ricardo H.

AU - Croxatto, Horacio B.

AU - Diaz, Soledad

AU - Pavez, Margarita

AU - Coutinho, Elsimar M.

AU - Rivera, Roberto

AU - Goldsmith, Alfredo

PY - 1984/1/1

Y1 - 1984/1/1

N2 - Long-acting, biodegradable, subcutaneous implants of fused pellets composed of norethindrone (NET) and pure cholestrol were evaluated in 50 healthy, normally menstruating volunteers from five clinics. Evaluation of serum NET levels indicated a steady release rate over the 6-cycle follow-up period. There were no serious local reactions to the pellets. Menstrual cycle length remained unchanged, but the incidence of intermenstrual bleeding and/or spotting was higher during the initial 2-3 months of pellet use. Following pellet removal menstrual cycle parameters returned to their pre-pellet implantation values. Serum gonadotropin assays indicated the incidence of ovulatory cycles increased over the follow-up period. No significant changes in serum lipoproteins, SMAC-12 or enzyme profiles were observed. Although women were advised to use additional methods of contraception, three became pregnant while using the implants. Fibrous tissue was noted to form around the pellets, thus limiting the release of NET. Additional trials of higher NET doses are being evaluated.

AB - Long-acting, biodegradable, subcutaneous implants of fused pellets composed of norethindrone (NET) and pure cholestrol were evaluated in 50 healthy, normally menstruating volunteers from five clinics. Evaluation of serum NET levels indicated a steady release rate over the 6-cycle follow-up period. There were no serious local reactions to the pellets. Menstrual cycle length remained unchanged, but the incidence of intermenstrual bleeding and/or spotting was higher during the initial 2-3 months of pellet use. Following pellet removal menstrual cycle parameters returned to their pre-pellet implantation values. Serum gonadotropin assays indicated the incidence of ovulatory cycles increased over the follow-up period. No significant changes in serum lipoproteins, SMAC-12 or enzyme profiles were observed. Although women were advised to use additional methods of contraception, three became pregnant while using the implants. Fibrous tissue was noted to form around the pellets, thus limiting the release of NET. Additional trials of higher NET doses are being evaluated.

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DO - 10.1016/0010-7824(84)90087-8

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VL - 30

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JO - Contraception

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SN - 0010-7824

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Program for Applied Research on Fertility Regulation FAROFR, N. Gupta G, Landesman R, Saxena BB, Singh M, Asch RH y otros. Multicenter clinical trial of implanted norethindrone pellets for long-acting contraception in women. Contraception. 1984 ene 1;30(3):239-252. https://doi.org/10.1016/0010-7824(84)90087-8