Pharmacokinetics of 7 alpha-methyl-19-nortestosterone (MENT) delivery using subdermal implants in healthy men.
Contraception
; 60(5): 299-303, 1999 Nov.
Article
en En
| MEDLINE
| ID: mdl-10717782
ABSTRACT
PIP: The authors studied the pharmacokinetics of 112 +or- 4 mg of MENT acetate in a polyethylene vinyl acetate copolymer. MENT acetate released from the implants is rapidly hydrolyzed to MENT in vivo. 15 healthy Finnish men were randomized to have either 1, 2, or 4 implants inserted in the medial aspect of the upper arm. The implants remained in place for 4 weeks. Blood samples were obtained before implant insertion, 1, 2, 3, and 4 weeks after insertion, and 1 and 2 weeks after removal. Serum MENT concentrations were determined by gas chromatography with mass selective detection. The MENT levels attained in each implant group remained at a steady level during the 4 weeks of implant use. The mean steady state MENT concentrations in the 1, 2, and 4 implant groups were 0.6, 1.4, and 2.3 nmol/l, respectively. Serum MENT concentrations during implant use were clearly dose dependent; the between-subject effect of implants as well as the differences between each pair of groups were all statistically significant. The release rate of MENT from 1, 2, and 4 implants was calculated to be approximately 0.3, 0.8, and 1.3 mg/day, respectively. The study suggests that MENT acetate implants are a promising method for long-term androgen administration in hypogonadism and male contraception.
Palabras clave
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Congéneres de la Testosterona
/
Estrenos
Tipo de estudio:
Clinical_trials
Límite:
Adult
/
Humans
/
Male
País/Región como asunto:
Europa
Idioma:
En
Revista:
Contraception
Año:
1999
Tipo del documento:
Article
País de afiliación:
Finlandia
Pais de publicación:
Estados Unidos