A Multicenter Phase IIb Study of a Novel Combination of Intramuscular Androgen (Testosterone Decanoate) and Oral Progestogen (Etonogestrel) for Male Hormonal Contraception
The effect of a novel combination of oral etonogestrel (ENG) and im testosterone decanoate (TD) on suppression of gonadotropins and spermatogenesis as a potential lead for male contraception was investigated. Healthy male volunteers were randomized into two groups receiving 300 μg ENG daily and 400...
Gespeichert in:
| Veröffentlicht in: | The journal of clinical endocrinology and metabolism 2005-04, Vol.90 (4), p.2042-2049 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 2049 |
|---|---|
| container_issue | 4 |
| container_start_page | 2042 |
| container_title | The journal of clinical endocrinology and metabolism |
| container_volume | 90 |
| creator | Hay, Cathy J. Brady, Brian M. Zitzmann, Michael Osmanagaoglu, Kaan Pollanen, Pasi Apter, Dan Wu, Frederick C. W. Anderson, Richard A. Nieschlag, Eberhard Devroey, Paul Huhtaniemi, Ilpo Kersemaekers, Wendy M. |
| description | The effect of a novel combination of oral etonogestrel (ENG) and im testosterone decanoate (TD) on suppression of gonadotropins and spermatogenesis as a potential lead for male contraception was investigated. Healthy male volunteers were randomized into two groups receiving 300 μg ENG daily and 400 mg TD every 4 (n = 55) or 6 (n = 57) wk for 48 wk. At wk 48, all men except one in the 6-wk group suppressed sperm concentration to less than 1 million/ml. Faster suppression occurred in the 4-wk group. Gonadotropins were suppressed in both groups and most consistently in the 4-wk group. During treatment, trough testosterone levels increased into the normal range in the 4-wk group but remained just below normal in the 6-wk group. All peak levels were within the normal range. After treatment cessation, recovery of sperm counts and gonadotropins to normal levels occurred in both groups. Minor effects on weight and cholesterol were noted. Fourteen subjects withdrew because of an adverse event with those possibly related to the study medication reported more frequently in the 6-wk group (nine vs. one). In conclusion, the combination of 300 μg ENG with 400 mg TD every 4 wk was superior in terms of efficacy, hormone profiles, and safety. This represents a promising approach to male hormonal contraception. |
| doi_str_mv | 10.1210/jc.2004-0895 |
| format | Article |
| fullrecord | <record><control><sourceid>pubmed_cross</sourceid><recordid>TN_cdi_crossref_primary_10_1210_jc_2004_0895</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>15671109</sourcerecordid><originalsourceid>FETCH-LOGICAL-c426t-95edcb574158c191084535acc309cde3942b208f0d3087319305ded3d4c82b4b3</originalsourceid><addsrcrecordid>eNpt0E1r3DAQBmBRWppN0lvPRZdCA3Wiz7V1XDZJs5A0gabQmxlL49aLLS2SXMhvyp-snV3IpScx4mFe5iXkI2fnXHB2sbXngjFVsMroN2TBjdJFyU35liwYE7wwpfh1RI5T2jLGldLyPTniellyzsyCPK_o3djnzqLPGOnDH0hIN5uG_sije6KhpUC_h7_Y03UYms5D7oKfvzc-RxjGZMceIl15F8Nv9PTLI6Yc0rQreKSXaMEHyHhGwTt6H6GnDzOczIu-ysG_jBH7M9qGSO-gR3oT4hA8zKFzjMXdHHtK3rXQJ_xweE_Iz-urx_VNcXv_bbNe3RZWiWUujEZnG10qrivLDWfVdLQGayUz1qE0SjSCVS1zklWl5EYy7dBJp2wlGtXIE_J1v9fGkFLEtt7FboD4VHNWz53XW1vPnddz5xP_tOe7sRnQveJDyRP4fACQLPRtBG-79OqWy6oUWk1O7h16F2zsPO4iplRvwxinMtL_4_8B5c6ctQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>A Multicenter Phase IIb Study of a Novel Combination of Intramuscular Androgen (Testosterone Decanoate) and Oral Progestogen (Etonogestrel) for Male Hormonal Contraception</title><source>Oxford University Press Journals All Titles (1996-Current)</source><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><creator>Hay, Cathy J. ; Brady, Brian M. ; Zitzmann, Michael ; Osmanagaoglu, Kaan ; Pollanen, Pasi ; Apter, Dan ; Wu, Frederick C. W. ; Anderson, Richard A. ; Nieschlag, Eberhard ; Devroey, Paul ; Huhtaniemi, Ilpo ; Kersemaekers, Wendy M.</creator><creatorcontrib>Hay, Cathy J. ; Brady, Brian M. ; Zitzmann, Michael ; Osmanagaoglu, Kaan ; Pollanen, Pasi ; Apter, Dan ; Wu, Frederick C. W. ; Anderson, Richard A. ; Nieschlag, Eberhard ; Devroey, Paul ; Huhtaniemi, Ilpo ; Kersemaekers, Wendy M.</creatorcontrib><description>The effect of a novel combination of oral etonogestrel (ENG) and im testosterone decanoate (TD) on suppression of gonadotropins and spermatogenesis as a potential lead for male contraception was investigated. Healthy male volunteers were randomized into two groups receiving 300 μg ENG daily and 400 mg TD every 4 (n = 55) or 6 (n = 57) wk for 48 wk. At wk 48, all men except one in the 6-wk group suppressed sperm concentration to less than 1 million/ml. Faster suppression occurred in the 4-wk group. Gonadotropins were suppressed in both groups and most consistently in the 4-wk group. During treatment, trough testosterone levels increased into the normal range in the 4-wk group but remained just below normal in the 6-wk group. All peak levels were within the normal range. After treatment cessation, recovery of sperm counts and gonadotropins to normal levels occurred in both groups. Minor effects on weight and cholesterol were noted. Fourteen subjects withdrew because of an adverse event with those possibly related to the study medication reported more frequently in the 6-wk group (nine vs. one). In conclusion, the combination of 300 μg ENG with 400 mg TD every 4 wk was superior in terms of efficacy, hormone profiles, and safety. This represents a promising approach to male hormonal contraception.</description><identifier>ISSN: 0021-972X</identifier><identifier>EISSN: 1945-7197</identifier><identifier>DOI: 10.1210/jc.2004-0895</identifier><identifier>PMID: 15671109</identifier><identifier>CODEN: JCEMAZ</identifier><language>eng</language><publisher>Bethesda, MD: Endocrine Society</publisher><subject>Administration, Oral ; Adolescent ; Adult ; Biological and medical sciences ; Body Weight - drug effects ; Contraception ; Desogestrel - administration & dosage ; Desogestrel - adverse effects ; Endocrinopathies ; Follicle Stimulating Hormone - blood ; Fundamental and applied biological sciences. Psychology ; Humans ; Injections, Intramuscular ; Lipids - blood ; Luteinizing Hormone - blood ; Male ; Medical sciences ; Middle Aged ; Sperm Count ; Testosterone - administration & dosage ; Testosterone - adverse effects ; Testosterone - analogs & derivatives ; Vertebrates: endocrinology</subject><ispartof>The journal of clinical endocrinology and metabolism, 2005-04, Vol.90 (4), p.2042-2049</ispartof><rights>2005 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c426t-95edcb574158c191084535acc309cde3942b208f0d3087319305ded3d4c82b4b3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16687254$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15671109$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hay, Cathy J.</creatorcontrib><creatorcontrib>Brady, Brian M.</creatorcontrib><creatorcontrib>Zitzmann, Michael</creatorcontrib><creatorcontrib>Osmanagaoglu, Kaan</creatorcontrib><creatorcontrib>Pollanen, Pasi</creatorcontrib><creatorcontrib>Apter, Dan</creatorcontrib><creatorcontrib>Wu, Frederick C. W.</creatorcontrib><creatorcontrib>Anderson, Richard A.</creatorcontrib><creatorcontrib>Nieschlag, Eberhard</creatorcontrib><creatorcontrib>Devroey, Paul</creatorcontrib><creatorcontrib>Huhtaniemi, Ilpo</creatorcontrib><creatorcontrib>Kersemaekers, Wendy M.</creatorcontrib><title>A Multicenter Phase IIb Study of a Novel Combination of Intramuscular Androgen (Testosterone Decanoate) and Oral Progestogen (Etonogestrel) for Male Hormonal Contraception</title><title>The journal of clinical endocrinology and metabolism</title><addtitle>J Clin Endocrinol Metab</addtitle><description>The effect of a novel combination of oral etonogestrel (ENG) and im testosterone decanoate (TD) on suppression of gonadotropins and spermatogenesis as a potential lead for male contraception was investigated. Healthy male volunteers were randomized into two groups receiving 300 μg ENG daily and 400 mg TD every 4 (n = 55) or 6 (n = 57) wk for 48 wk. At wk 48, all men except one in the 6-wk group suppressed sperm concentration to less than 1 million/ml. Faster suppression occurred in the 4-wk group. Gonadotropins were suppressed in both groups and most consistently in the 4-wk group. During treatment, trough testosterone levels increased into the normal range in the 4-wk group but remained just below normal in the 6-wk group. All peak levels were within the normal range. After treatment cessation, recovery of sperm counts and gonadotropins to normal levels occurred in both groups. Minor effects on weight and cholesterol were noted. Fourteen subjects withdrew because of an adverse event with those possibly related to the study medication reported more frequently in the 6-wk group (nine vs. one). In conclusion, the combination of 300 μg ENG with 400 mg TD every 4 wk was superior in terms of efficacy, hormone profiles, and safety. This represents a promising approach to male hormonal contraception.</description><subject>Administration, Oral</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Body Weight - drug effects</subject><subject>Contraception</subject><subject>Desogestrel - administration & dosage</subject><subject>Desogestrel - adverse effects</subject><subject>Endocrinopathies</subject><subject>Follicle Stimulating Hormone - blood</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Humans</subject><subject>Injections, Intramuscular</subject><subject>Lipids - blood</subject><subject>Luteinizing Hormone - blood</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Sperm Count</subject><subject>Testosterone - administration & dosage</subject><subject>Testosterone - adverse effects</subject><subject>Testosterone - analogs & derivatives</subject><subject>Vertebrates: endocrinology</subject><issn>0021-972X</issn><issn>1945-7197</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpt0E1r3DAQBmBRWppN0lvPRZdCA3Wiz7V1XDZJs5A0gabQmxlL49aLLS2SXMhvyp-snV3IpScx4mFe5iXkI2fnXHB2sbXngjFVsMroN2TBjdJFyU35liwYE7wwpfh1RI5T2jLGldLyPTniellyzsyCPK_o3djnzqLPGOnDH0hIN5uG_sije6KhpUC_h7_Y03UYms5D7oKfvzc-RxjGZMceIl15F8Nv9PTLI6Yc0rQreKSXaMEHyHhGwTt6H6GnDzOczIu-ysG_jBH7M9qGSO-gR3oT4hA8zKFzjMXdHHtK3rXQJ_xweE_Iz-urx_VNcXv_bbNe3RZWiWUujEZnG10qrivLDWfVdLQGayUz1qE0SjSCVS1zklWl5EYy7dBJp2wlGtXIE_J1v9fGkFLEtt7FboD4VHNWz53XW1vPnddz5xP_tOe7sRnQveJDyRP4fACQLPRtBG-79OqWy6oUWk1O7h16F2zsPO4iplRvwxinMtL_4_8B5c6ctQ</recordid><startdate>20050401</startdate><enddate>20050401</enddate><creator>Hay, Cathy J.</creator><creator>Brady, Brian M.</creator><creator>Zitzmann, Michael</creator><creator>Osmanagaoglu, Kaan</creator><creator>Pollanen, Pasi</creator><creator>Apter, Dan</creator><creator>Wu, Frederick C. W.</creator><creator>Anderson, Richard A.</creator><creator>Nieschlag, Eberhard</creator><creator>Devroey, Paul</creator><creator>Huhtaniemi, Ilpo</creator><creator>Kersemaekers, Wendy M.</creator><general>Endocrine Society</general><scope>IQODW</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></search><sort><creationdate>20050401</creationdate><title>A Multicenter Phase IIb Study of a Novel Combination of Intramuscular Androgen (Testosterone Decanoate) and Oral Progestogen (Etonogestrel) for Male Hormonal Contraception</title><author>Hay, Cathy J. ; Brady, Brian M. ; Zitzmann, Michael ; Osmanagaoglu, Kaan ; Pollanen, Pasi ; Apter, Dan ; Wu, Frederick C. W. ; Anderson, Richard A. ; Nieschlag, Eberhard ; Devroey, Paul ; Huhtaniemi, Ilpo ; Kersemaekers, Wendy M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c426t-95edcb574158c191084535acc309cde3942b208f0d3087319305ded3d4c82b4b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Administration, Oral</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Biological and medical sciences</topic><topic>Body Weight - drug effects</topic><topic>Contraception</topic><topic>Desogestrel - administration & dosage</topic><topic>Desogestrel - adverse effects</topic><topic>Endocrinopathies</topic><topic>Follicle Stimulating Hormone - blood</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Humans</topic><topic>Injections, Intramuscular</topic><topic>Lipids - blood</topic><topic>Luteinizing Hormone - blood</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Sperm Count</topic><topic>Testosterone - administration & dosage</topic><topic>Testosterone - adverse effects</topic><topic>Testosterone - analogs & derivatives</topic><topic>Vertebrates: endocrinology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hay, Cathy J.</creatorcontrib><creatorcontrib>Brady, Brian M.</creatorcontrib><creatorcontrib>Zitzmann, Michael</creatorcontrib><creatorcontrib>Osmanagaoglu, Kaan</creatorcontrib><creatorcontrib>Pollanen, Pasi</creatorcontrib><creatorcontrib>Apter, Dan</creatorcontrib><creatorcontrib>Wu, Frederick C. W.</creatorcontrib><creatorcontrib>Anderson, Richard A.</creatorcontrib><creatorcontrib>Nieschlag, Eberhard</creatorcontrib><creatorcontrib>Devroey, Paul</creatorcontrib><creatorcontrib>Huhtaniemi, Ilpo</creatorcontrib><creatorcontrib>Kersemaekers, Wendy M.</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><jtitle>The journal of clinical endocrinology and metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hay, Cathy J.</au><au>Brady, Brian M.</au><au>Zitzmann, Michael</au><au>Osmanagaoglu, Kaan</au><au>Pollanen, Pasi</au><au>Apter, Dan</au><au>Wu, Frederick C. W.</au><au>Anderson, Richard A.</au><au>Nieschlag, Eberhard</au><au>Devroey, Paul</au><au>Huhtaniemi, Ilpo</au><au>Kersemaekers, Wendy M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Multicenter Phase IIb Study of a Novel Combination of Intramuscular Androgen (Testosterone Decanoate) and Oral Progestogen (Etonogestrel) for Male Hormonal Contraception</atitle><jtitle>The journal of clinical endocrinology and metabolism</jtitle><addtitle>J Clin Endocrinol Metab</addtitle><date>2005-04-01</date><risdate>2005</risdate><volume>90</volume><issue>4</issue><spage>2042</spage><epage>2049</epage><pages>2042-2049</pages><issn>0021-972X</issn><eissn>1945-7197</eissn><coden>JCEMAZ</coden><abstract>The effect of a novel combination of oral etonogestrel (ENG) and im testosterone decanoate (TD) on suppression of gonadotropins and spermatogenesis as a potential lead for male contraception was investigated. Healthy male volunteers were randomized into two groups receiving 300 μg ENG daily and 400 mg TD every 4 (n = 55) or 6 (n = 57) wk for 48 wk. At wk 48, all men except one in the 6-wk group suppressed sperm concentration to less than 1 million/ml. Faster suppression occurred in the 4-wk group. Gonadotropins were suppressed in both groups and most consistently in the 4-wk group. During treatment, trough testosterone levels increased into the normal range in the 4-wk group but remained just below normal in the 6-wk group. All peak levels were within the normal range. After treatment cessation, recovery of sperm counts and gonadotropins to normal levels occurred in both groups. Minor effects on weight and cholesterol were noted. Fourteen subjects withdrew because of an adverse event with those possibly related to the study medication reported more frequently in the 6-wk group (nine vs. one). In conclusion, the combination of 300 μg ENG with 400 mg TD every 4 wk was superior in terms of efficacy, hormone profiles, and safety. This represents a promising approach to male hormonal contraception.</abstract><cop>Bethesda, MD</cop><pub>Endocrine Society</pub><pmid>15671109</pmid><doi>10.1210/jc.2004-0895</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0021-972X |
| ispartof | The journal of clinical endocrinology and metabolism, 2005-04, Vol.90 (4), p.2042-2049 |
| issn | 0021-972X 1945-7197 |
| language | eng |
| recordid | cdi_crossref_primary_10_1210_jc_2004_0895 |
| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Administration, Oral Adolescent Adult Biological and medical sciences Body Weight - drug effects Contraception Desogestrel - administration & dosage Desogestrel - adverse effects Endocrinopathies Follicle Stimulating Hormone - blood Fundamental and applied biological sciences. Psychology Humans Injections, Intramuscular Lipids - blood Luteinizing Hormone - blood Male Medical sciences Middle Aged Sperm Count Testosterone - administration & dosage Testosterone - adverse effects Testosterone - analogs & derivatives Vertebrates: endocrinology |
| title | A Multicenter Phase IIb Study of a Novel Combination of Intramuscular Androgen (Testosterone Decanoate) and Oral Progestogen (Etonogestrel) for Male Hormonal Contraception |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-06T00%3A47%3A44IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-pubmed_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20Multicenter%20Phase%20IIb%20Study%20of%20a%20Novel%20Combination%20of%20Intramuscular%20Androgen%20(Testosterone%20Decanoate)%20and%20Oral%20Progestogen%20(Etonogestrel)%20for%20Male%20Hormonal%20Contraception&rft.jtitle=The%20journal%20of%20clinical%20endocrinology%20and%20metabolism&rft.au=Hay,%20Cathy%20J.&rft.date=2005-04-01&rft.volume=90&rft.issue=4&rft.spage=2042&rft.epage=2049&rft.pages=2042-2049&rft.issn=0021-972X&rft.eissn=1945-7197&rft.coden=JCEMAZ&rft_id=info:doi/10.1210/jc.2004-0895&rft_dat=%3Cpubmed_cross%3E15671109%3C/pubmed_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_id=info:pmid/15671109&rfr_iscdi=true |