Efficacy and Safety Study of 1.62% Testosterone Gel for the Treatment of Hypogonadal Men
Male hypogonadism is a significant and growing problem that can be successfully treated with testosterone replacement therapy. A new formulation of testosterone gel (1.62%) was developed with increased viscosity, reduced volume of application, and increased skin permeation compared with other curren...
Gespeichert in:
| Veröffentlicht in: | Journal of sexual medicine 2011-07, Vol.8 (7), p.2079-2089 |
|---|---|
| Hauptverfasser: | , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 2089 |
|---|---|
| container_issue | 7 |
| container_start_page | 2079 |
| container_title | Journal of sexual medicine |
| container_volume | 8 |
| creator | Kaufman, Joel M. Miller, Michael G. Garwin, Jeffrey L. Fitzpatrick, Sherahe McWhirter, Cecilia Brennan, John J. |
| description | Male hypogonadism is a significant and growing problem that can be successfully treated with testosterone replacement therapy. A new formulation of testosterone gel (1.62%) was developed with increased viscosity, reduced volume of application, and increased skin permeation compared with other currently available testosterone gels.
To evaluate the efficacy and safety of titrated doses of 1.62% testosterone gel after daily application to the skin of hypogonadal men for 182 days.
This was a multicenter, randomized, double‐blind, placebo‐controlled study in hypogonadal men (234 active; 40 placebo), 18 to 80 years of age with average serum total testosterone concentrations |
| doi_str_mv | 10.1111/j.1743-6109.2011.02265.x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_878030978</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S1743609515335803</els_id><sourcerecordid>878030978</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4655-a382f6965f3e6d6295ce99764e2713441c122a2dde825c1dd422aed238ce506f3</originalsourceid><addsrcrecordid>eNqNkEtv1DAURiMEoqXwF5A3iFWCH7ETL1jQqmRKHyxmEOwsY19Dhkw82Bk6-fd1mna29G58LZ_v2j5ZhgguSKoP64JUJcsFwbKgmJACUyp4sX-WHR8Onj_2WPKj7FWMa4xZKvoyO6KklLTE-Dj7ce5ca7QZke4tWmoHw4iWw86OyDtECkHfoRXEwccBgu8BNdAh5wMafgNaBdDDBvphYhfj1v_yvba6Q9fQv85eON1FePOwnmTfPp-vzhb51dfm4uzTVW5KwXmuWU2dkII7BsIKKrkBKStRAq0IK0tiCKWaWgs15YZYW6YtWMpqAxwLx06y9_PcbfB_d-mlatNGA12ne_C7qOqqxgzLqk5kPZMm-BgDOLUN7UaHURGsJq1qrSZjarKnJq3qXqvap-jbh0t2PzdgD8FHjwn4OAO3bQfjkwerL8vrqUv5fM63yfP-kNfhjxIVq7j6ftOoRSNPm8slVzeJP515SGr_tRBUNC30BmwbwAzK-vb_v7oDo6yoSQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>878030978</pqid></control><display><type>article</type><title>Efficacy and Safety Study of 1.62% Testosterone Gel for the Treatment of Hypogonadal Men</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><source>Oxford University Press Journals All Titles (1996-Current)</source><creator>Kaufman, Joel M. ; Miller, Michael G. ; Garwin, Jeffrey L. ; Fitzpatrick, Sherahe ; McWhirter, Cecilia ; Brennan, John J.</creator><creatorcontrib>Kaufman, Joel M. ; Miller, Michael G. ; Garwin, Jeffrey L. ; Fitzpatrick, Sherahe ; McWhirter, Cecilia ; Brennan, John J.</creatorcontrib><description>Male hypogonadism is a significant and growing problem that can be successfully treated with testosterone replacement therapy. A new formulation of testosterone gel (1.62%) was developed with increased viscosity, reduced volume of application, and increased skin permeation compared with other currently available testosterone gels.
To evaluate the efficacy and safety of titrated doses of 1.62% testosterone gel after daily application to the skin of hypogonadal men for 182 days.
This was a multicenter, randomized, double‐blind, placebo‐controlled study in hypogonadal men (234 active; 40 placebo), 18 to 80 years of age with average serum total testosterone concentrations <300 ng/dL and prostate‐specific antigen <2.5 ng/mL. Topical testosterone gel (1.62%), 1.25 g, 2.5 g, 3.75 g, and 5.0 g, or placebo gel was applied once daily to either upper arms/shoulders or abdomen. Dose adjustments were made on days 14, 28, and 42.
The percentage of subjects with serum total testosterone average concentrations (Cav) within the normal range of 300–1,000 ng/dL on study days 14, 56, 112, and 182.
Following titration, significantly (P < 0.0001) more subjects receiving active treatment had testosterone Cav values (range 81.6% to 82.5%) within the eugonadal range compared with placebo (range 28.6% to 37.0%) on all study days. The 1.62% gel was safe and well tolerated.
In this study, treatment with 1.62% testosterone gel was safe and efficacious, resulting in an acceptable percentage of hypogonadal males achieving eugonadal serum testosterone levels. Kaufman JM, Miller MG, Garwin JL, Fitzpatrick S, McWhirter C, and Brennan JJ. Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men. J Sex Med 2011;8:2079–2089.</description><identifier>ISSN: 1743-6095</identifier><identifier>EISSN: 1743-6109</identifier><identifier>DOI: 10.1111/j.1743-6109.2011.02265.x</identifier><identifier>PMID: 21492400</identifier><language>eng</language><publisher>Malden, USA: Elsevier Inc</publisher><subject>1.62% Testosterone Gel ; Administration, Topical ; Adult ; Aged ; Androgens ; Androgens - administration & dosage ; Dose-Response Relationship, Drug ; Double-Blind Method ; Gels - administration & dosage ; Humans ; Hypogonadism ; Hypogonadism - drug therapy ; Male ; Middle Aged ; Pharmacodynamics ; Pharmacokinetics ; Testosterone - administration & dosage ; Testosterone Replacement Therapy ; Treatment Outcome</subject><ispartof>Journal of sexual medicine, 2011-07, Vol.8 (7), p.2079-2089</ispartof><rights>2011 International Society for Sexual Medicine</rights><rights>2011 International Society for Sexual Medicine.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4655-a382f6965f3e6d6295ce99764e2713441c122a2dde825c1dd422aed238ce506f3</citedby><cites>FETCH-LOGICAL-c4655-a382f6965f3e6d6295ce99764e2713441c122a2dde825c1dd422aed238ce506f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1743-6109.2011.02265.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1743-6109.2011.02265.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,778,782,1414,27911,27912,45561,45562</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21492400$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kaufman, Joel M.</creatorcontrib><creatorcontrib>Miller, Michael G.</creatorcontrib><creatorcontrib>Garwin, Jeffrey L.</creatorcontrib><creatorcontrib>Fitzpatrick, Sherahe</creatorcontrib><creatorcontrib>McWhirter, Cecilia</creatorcontrib><creatorcontrib>Brennan, John J.</creatorcontrib><title>Efficacy and Safety Study of 1.62% Testosterone Gel for the Treatment of Hypogonadal Men</title><title>Journal of sexual medicine</title><addtitle>J Sex Med</addtitle><description>Male hypogonadism is a significant and growing problem that can be successfully treated with testosterone replacement therapy. A new formulation of testosterone gel (1.62%) was developed with increased viscosity, reduced volume of application, and increased skin permeation compared with other currently available testosterone gels.
To evaluate the efficacy and safety of titrated doses of 1.62% testosterone gel after daily application to the skin of hypogonadal men for 182 days.
This was a multicenter, randomized, double‐blind, placebo‐controlled study in hypogonadal men (234 active; 40 placebo), 18 to 80 years of age with average serum total testosterone concentrations <300 ng/dL and prostate‐specific antigen <2.5 ng/mL. Topical testosterone gel (1.62%), 1.25 g, 2.5 g, 3.75 g, and 5.0 g, or placebo gel was applied once daily to either upper arms/shoulders or abdomen. Dose adjustments were made on days 14, 28, and 42.
The percentage of subjects with serum total testosterone average concentrations (Cav) within the normal range of 300–1,000 ng/dL on study days 14, 56, 112, and 182.
Following titration, significantly (P < 0.0001) more subjects receiving active treatment had testosterone Cav values (range 81.6% to 82.5%) within the eugonadal range compared with placebo (range 28.6% to 37.0%) on all study days. The 1.62% gel was safe and well tolerated.
In this study, treatment with 1.62% testosterone gel was safe and efficacious, resulting in an acceptable percentage of hypogonadal males achieving eugonadal serum testosterone levels. Kaufman JM, Miller MG, Garwin JL, Fitzpatrick S, McWhirter C, and Brennan JJ. Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men. J Sex Med 2011;8:2079–2089.</description><subject>1.62% Testosterone Gel</subject><subject>Administration, Topical</subject><subject>Adult</subject><subject>Aged</subject><subject>Androgens</subject><subject>Androgens - administration & dosage</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Gels - administration & dosage</subject><subject>Humans</subject><subject>Hypogonadism</subject><subject>Hypogonadism - drug therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pharmacodynamics</subject><subject>Pharmacokinetics</subject><subject>Testosterone - administration & dosage</subject><subject>Testosterone Replacement Therapy</subject><subject>Treatment Outcome</subject><issn>1743-6095</issn><issn>1743-6109</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkEtv1DAURiMEoqXwF5A3iFWCH7ETL1jQqmRKHyxmEOwsY19Dhkw82Bk6-fd1mna29G58LZ_v2j5ZhgguSKoP64JUJcsFwbKgmJACUyp4sX-WHR8Onj_2WPKj7FWMa4xZKvoyO6KklLTE-Dj7ce5ca7QZke4tWmoHw4iWw86OyDtECkHfoRXEwccBgu8BNdAh5wMafgNaBdDDBvphYhfj1v_yvba6Q9fQv85eON1FePOwnmTfPp-vzhb51dfm4uzTVW5KwXmuWU2dkII7BsIKKrkBKStRAq0IK0tiCKWaWgs15YZYW6YtWMpqAxwLx06y9_PcbfB_d-mlatNGA12ne_C7qOqqxgzLqk5kPZMm-BgDOLUN7UaHURGsJq1qrSZjarKnJq3qXqvap-jbh0t2PzdgD8FHjwn4OAO3bQfjkwerL8vrqUv5fM63yfP-kNfhjxIVq7j6ftOoRSNPm8slVzeJP515SGr_tRBUNC30BmwbwAzK-vb_v7oDo6yoSQ</recordid><startdate>201107</startdate><enddate>201107</enddate><creator>Kaufman, Joel M.</creator><creator>Miller, Michael G.</creator><creator>Garwin, Jeffrey L.</creator><creator>Fitzpatrick, Sherahe</creator><creator>McWhirter, Cecilia</creator><creator>Brennan, John J.</creator><general>Elsevier Inc</general><general>Blackwell Publishing Inc</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201107</creationdate><title>Efficacy and Safety Study of 1.62% Testosterone Gel for the Treatment of Hypogonadal Men</title><author>Kaufman, Joel M. ; Miller, Michael G. ; Garwin, Jeffrey L. ; Fitzpatrick, Sherahe ; McWhirter, Cecilia ; Brennan, John J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4655-a382f6965f3e6d6295ce99764e2713441c122a2dde825c1dd422aed238ce506f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>1.62% Testosterone Gel</topic><topic>Administration, Topical</topic><topic>Adult</topic><topic>Aged</topic><topic>Androgens</topic><topic>Androgens - administration & dosage</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Gels - administration & dosage</topic><topic>Humans</topic><topic>Hypogonadism</topic><topic>Hypogonadism - drug therapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pharmacodynamics</topic><topic>Pharmacokinetics</topic><topic>Testosterone - administration & dosage</topic><topic>Testosterone Replacement Therapy</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kaufman, Joel M.</creatorcontrib><creatorcontrib>Miller, Michael G.</creatorcontrib><creatorcontrib>Garwin, Jeffrey L.</creatorcontrib><creatorcontrib>Fitzpatrick, Sherahe</creatorcontrib><creatorcontrib>McWhirter, Cecilia</creatorcontrib><creatorcontrib>Brennan, John J.</creatorcontrib><collection>Istex</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>Journal of sexual medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kaufman, Joel M.</au><au>Miller, Michael G.</au><au>Garwin, Jeffrey L.</au><au>Fitzpatrick, Sherahe</au><au>McWhirter, Cecilia</au><au>Brennan, John J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Safety Study of 1.62% Testosterone Gel for the Treatment of Hypogonadal Men</atitle><jtitle>Journal of sexual medicine</jtitle><addtitle>J Sex Med</addtitle><date>2011-07</date><risdate>2011</risdate><volume>8</volume><issue>7</issue><spage>2079</spage><epage>2089</epage><pages>2079-2089</pages><issn>1743-6095</issn><eissn>1743-6109</eissn><abstract>Male hypogonadism is a significant and growing problem that can be successfully treated with testosterone replacement therapy. A new formulation of testosterone gel (1.62%) was developed with increased viscosity, reduced volume of application, and increased skin permeation compared with other currently available testosterone gels.
To evaluate the efficacy and safety of titrated doses of 1.62% testosterone gel after daily application to the skin of hypogonadal men for 182 days.
This was a multicenter, randomized, double‐blind, placebo‐controlled study in hypogonadal men (234 active; 40 placebo), 18 to 80 years of age with average serum total testosterone concentrations <300 ng/dL and prostate‐specific antigen <2.5 ng/mL. Topical testosterone gel (1.62%), 1.25 g, 2.5 g, 3.75 g, and 5.0 g, or placebo gel was applied once daily to either upper arms/shoulders or abdomen. Dose adjustments were made on days 14, 28, and 42.
The percentage of subjects with serum total testosterone average concentrations (Cav) within the normal range of 300–1,000 ng/dL on study days 14, 56, 112, and 182.
Following titration, significantly (P < 0.0001) more subjects receiving active treatment had testosterone Cav values (range 81.6% to 82.5%) within the eugonadal range compared with placebo (range 28.6% to 37.0%) on all study days. The 1.62% gel was safe and well tolerated.
In this study, treatment with 1.62% testosterone gel was safe and efficacious, resulting in an acceptable percentage of hypogonadal males achieving eugonadal serum testosterone levels. Kaufman JM, Miller MG, Garwin JL, Fitzpatrick S, McWhirter C, and Brennan JJ. Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men. J Sex Med 2011;8:2079–2089.</abstract><cop>Malden, USA</cop><pub>Elsevier Inc</pub><pmid>21492400</pmid><doi>10.1111/j.1743-6109.2011.02265.x</doi><tpages>11</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1743-6095 |
| ispartof | Journal of sexual medicine, 2011-07, Vol.8 (7), p.2079-2089 |
| issn | 1743-6095 1743-6109 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_878030978 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; Oxford University Press Journals All Titles (1996-Current) |
| subjects | 1.62% Testosterone Gel Administration, Topical Adult Aged Androgens Androgens - administration & dosage Dose-Response Relationship, Drug Double-Blind Method Gels - administration & dosage Humans Hypogonadism Hypogonadism - drug therapy Male Middle Aged Pharmacodynamics Pharmacokinetics Testosterone - administration & dosage Testosterone Replacement Therapy Treatment Outcome |
| title | Efficacy and Safety Study of 1.62% Testosterone Gel for the Treatment of Hypogonadal Men |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-16T02%3A52%3A42IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Efficacy%20and%20Safety%20Study%20of%201.62%25%20Testosterone%20Gel%20for%20the%20Treatment%20of%20Hypogonadal%20Men&rft.jtitle=Journal%20of%20sexual%20medicine&rft.au=Kaufman,%20Joel%20M.&rft.date=2011-07&rft.volume=8&rft.issue=7&rft.spage=2079&rft.epage=2089&rft.pages=2079-2089&rft.issn=1743-6095&rft.eissn=1743-6109&rft_id=info:doi/10.1111/j.1743-6109.2011.02265.x&rft_dat=%3Cproquest_cross%3E878030978%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=878030978&rft_id=info:pmid/21492400&rft_els_id=S1743609515335803&rfr_iscdi=true |