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 original | English |
|---|---|
| Páginas (desde-hasta) | 33-38 |
| Número de páginas | 6 |
| Publicación | Contraception |
| Volumen | 51 |
| N.º | 1 |
| DOI | |
| Estado | Published - 1 ene 1995 |
Huella dactilar
ASJC Scopus subject areas
- Reproductive Medicine
- Obstetrics and Gynaecology
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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
TY - JOUR
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.
PY - 1995/1/1
Y1 - 1995/1/1
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.
KW - contraception
KW - implant
KW - Nestorone
KW - progestin
KW - Silastic
KW - ST-1435
UR - http://www.scopus.com/inward/record.url?scp=0028871110&partnerID=8YFLogxK
U2 - 10.1016/0010-7824(94)00006-I
DO - 10.1016/0010-7824(94)00006-I
M3 - Article
C2 - 7750282
AN - SCOPUS:0028871110
VL - 51
SP - 33
EP - 38
JO - Contraception
JF - Contraception
SN - 0010-7824
IS - 1
ER -