Pharmacokinetics of 7α-methyl-19-nortestosterone (MENT™) delivery using subdermal implants in healthy men

We studied the pharmacokinetics of 7α-methyl-19-nortestosterone (MENT), a potent synthetic androgen, administered by subdermal implants. The implants contained 112 ± 4 mg of MENT acetate in a polyethylene vinyl acetate copolymer. MENT acetate released from the implants is rapidly hydrolyzed to MENT...

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Veröffentlicht in:Contraception (Stoneham) 1999-11, Vol.60 (5), p.299-303
Hauptverfasser: Suvisaari, Janne, Moo-Young, Alfred, Juhakoski, Auni, Elomaa, Kaisa, Saleh, Saleh I, Lähteenmäki, Pekka
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container_end_page 303
container_issue 5
container_start_page 299
container_title Contraception (Stoneham)
container_volume 60
creator Suvisaari, Janne
Moo-Young, Alfred
Juhakoski, Auni
Elomaa, Kaisa
Saleh, Saleh I
Lähteenmäki, Pekka
description We studied the pharmacokinetics of 7α-methyl-19-nortestosterone (MENT), a potent synthetic androgen, administered by subdermal implants. The implants contained 112 ± 4 mg of MENT acetate in a polyethylene vinyl acetate copolymer. MENT acetate released from the implants is rapidly hydrolyzed to MENT in vivo. Fifteen healthy Finnish men were randomized to have either one, two, or four 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 one, two, and four 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 one, two, and four implants was calculated to be approximately 0.3, 0.8, and 1.3 mg/day, respectively. This study suggests that MENT acetate implants are a promising method for long-term androgen administration in hypogonadism and male contraception.
doi_str_mv 10.1016/S0010-7824(99)00095-5
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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 one, two, and four implants was calculated to be approximately 0.3, 0.8, and 1.3 mg/day, respectively. This study suggests that MENT acetate implants are a promising method for long-term androgen administration in hypogonadism and male contraception.</description><subject>7α-methyl-19-nortestosterone</subject><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Birth control</subject><subject>Chromatography, Gas</subject><subject>Drug Implants</subject><subject>Estrenes - administration &amp; dosage</subject><subject>Estrenes - blood</subject><subject>Estrenes - pharmacokinetics</subject><subject>Finland</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>implants</subject><subject>Kinetics</subject><subject>Male</subject><subject>male contraception</subject><subject>Medical sciences</subject><subject>MENT</subject><subject>Other methods of contraception. 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Andrology. Obstetrics</topic><topic>Humans</topic><topic>implants</topic><topic>Kinetics</topic><topic>Male</topic><topic>male contraception</topic><topic>Medical sciences</topic><topic>MENT</topic><topic>Other methods of contraception. Sterilization</topic><topic>pharmacokinetics</topic><topic>Population</topic><topic>testosterone</topic><topic>Testosterone Congeners - administration &amp; dosage</topic><topic>Testosterone Congeners - pharmacokinetics</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Suvisaari, Janne</creatorcontrib><creatorcontrib>Moo-Young, Alfred</creatorcontrib><creatorcontrib>Juhakoski, Auni</creatorcontrib><creatorcontrib>Elomaa, Kaisa</creatorcontrib><creatorcontrib>Saleh, Saleh I</creatorcontrib><creatorcontrib>Lähteenmäki, Pekka</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Contraception (Stoneham)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Suvisaari, Janne</au><au>Moo-Young, Alfred</au><au>Juhakoski, Auni</au><au>Elomaa, Kaisa</au><au>Saleh, Saleh I</au><au>Lähteenmäki, Pekka</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetics of 7α-methyl-19-nortestosterone (MENT™) delivery using subdermal implants in healthy men</atitle><jtitle>Contraception (Stoneham)</jtitle><addtitle>Contraception</addtitle><date>1999-11-01</date><risdate>1999</risdate><volume>60</volume><issue>5</issue><spage>299</spage><epage>303</epage><pages>299-303</pages><issn>0010-7824</issn><eissn>1879-0518</eissn><coden>CCPTAY</coden><abstract>We studied the pharmacokinetics of 7α-methyl-19-nortestosterone (MENT), a potent synthetic androgen, administered by subdermal implants. 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identifier ISSN: 0010-7824
ispartof Contraception (Stoneham), 1999-11, Vol.60 (5), p.299-303
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subjects 7α-methyl-19-nortestosterone
Adult
Biological and medical sciences
Birth control
Chromatography, Gas
Drug Implants
Estrenes - administration & dosage
Estrenes - blood
Estrenes - pharmacokinetics
Finland
Gynecology. Andrology. Obstetrics
Humans
implants
Kinetics
Male
male contraception
Medical sciences
MENT
Other methods of contraception. Sterilization
pharmacokinetics
Population
testosterone
Testosterone Congeners - administration & dosage
Testosterone Congeners - pharmacokinetics
title Pharmacokinetics of 7α-methyl-19-nortestosterone (MENT™) delivery using subdermal implants in healthy men
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