Testosterone for Low Libido in Postmenopausal Women Not Taking Estrogen
Identifieur interne : 003185 ( PascalFrancis/Corpus ); précédent : 003184; suivant : 003186Testosterone for Low Libido in Postmenopausal Women Not Taking Estrogen
Auteurs : Susan R. Davis ; Michele Moreau ; Robin Kroll ; Céline Bouchard ; Nick Panay ; Margery Gass ; Glenn D. Braunstein ; Angelica Linden Hirschberg ; Cynthia Rodenberg ; Simon Pack ; Helga Koch ; Alain Moufarege ; John StuddSource :
- The New England journal of medicine [ 0028-4793 ] ; 2008.
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- Pascal (Inist)
English descriptors
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Abstract
BACKGROUND The efficacy and safety of testosterone treatment for hypoactive sexual desire disorder in postmenopausal women not receiving estrogen therapy are unknown. METHODS We conducted a double-blind, placebo-controlled, 52-week trial in which 814 women with hypoactive sexual desire disorder were randomly assigned to receive a patch delivering 150 or 300 μg of testosterone per day or placebo. Efficacy was measured to week 24; safety was evaluated over a period of 52 weeks, with a subgroup of participants followed for an additional year. The primary end point was the change from baseline to week 24 in the 4-week frequency of satisfying sexual episodes. RESULTS At 24 weeks, the increase in the 4-week frequency of satisfying sexual episodes was significantly greater in the group receiving 300 μg of testosterone per day than in the placebo group (an increase of 2.1 episodes vs. 0.7, P<0.001) but not in the group receiving 150 μg per day (1.2 episodes, P=0.11). As compared with placebo, both doses of testosterone were associated with significant increases in desire (300 μg per day, P<0.001; 150 μg per day, P=0.04) and decreases in distress (300 μg per day, P<0.001; 150 μg per day, P=0.04). The rate of androgenic adverse events - primarily unwanted hair growth - was higher in the group receiving 300 μg of testosterone per day than in the placebo group (30.0% vs. 23.1%). Breast cancer was diagnosed in four women who received testosterone (as compared with none who received placebo); one of the four received the diagnosis in the first 4 months of the study period, and one, in retrospect, had symptoms before undergoing randomization. CONCLUSIONS In postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 μg of testosterone per day resulted in a modest but meaningful improvement in sexual function. The long-term effects of testosterone, including effects on the breast, remain uncertain. (ClinicalTrials.gov number, NCT00131495.)
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Format Inist (serveur)
| NO : | PASCAL 08-0528793 INIST |
|---|---|
| ET : | Testosterone for Low Libido in Postmenopausal Women Not Taking Estrogen |
| AU : | DAVIS (Susan R.); MOREAU (Michele); KROLL (Robin); BOUCHARD (Céline); PANAY (Nick); GASS (Margery); BRAUNSTEIN (Glenn D.); LINDEN HIRSCHBERG (Angelica); RODENBERG (Cynthia); PACK (Simon); KOCH (Helga); MOUFAREGE (Alain); STUDD (John) |
| AF : | Women's Health Program, Monash University, Alfred Hospital/Prahran/Australie (1 aut.); Centre d'Etude Clinique/Montreal/Canada (2 aut.); Women's Clinical Research Center and the Menopause Center of Seattle/Seattle/Etats-Unis (3 aut.); Université Laval/Quebec, QC/Canada (4 aut.); Queen Charlotte's and Chelsea Hospital/London/Royaume-Uni (5 aut.); University of Cincinnati College of Medicine/Cincinnati/Etats-Unis (6 aut.); Cedars-Sinai Medical Center/Los Angeles/Etats-Unis (7 aut.); Karolinska University Hospital/Stockholm/Suède (8 aut.); Procter & Gamble Pharmaceuticals/Mason, OH/Etats-Unis (9 aut., 10 aut., 11 aut.); Debiopharm Group/Charenton-le-Pont/France (12 aut.); Chelsea and Westminster Hospital/London/Royaume-Uni (13 aut.) |
| DT : | Publication en série; Niveau analytique |
| SO : | The New England journal of medicine; ISSN 0028-4793; Coden NEJMAG; Etats-Unis; Da. 2008; Vol. 359; No. 19; Pp. 2005-2017; Bibl. 44 ref. |
| LA : | Anglais |
| EA : | BACKGROUND The efficacy and safety of testosterone treatment for hypoactive sexual desire disorder in postmenopausal women not receiving estrogen therapy are unknown. METHODS We conducted a double-blind, placebo-controlled, 52-week trial in which 814 women with hypoactive sexual desire disorder were randomly assigned to receive a patch delivering 150 or 300 μg of testosterone per day or placebo. Efficacy was measured to week 24; safety was evaluated over a period of 52 weeks, with a subgroup of participants followed for an additional year. The primary end point was the change from baseline to week 24 in the 4-week frequency of satisfying sexual episodes. RESULTS At 24 weeks, the increase in the 4-week frequency of satisfying sexual episodes was significantly greater in the group receiving 300 μg of testosterone per day than in the placebo group (an increase of 2.1 episodes vs. 0.7, P<0.001) but not in the group receiving 150 μg per day (1.2 episodes, P=0.11). As compared with placebo, both doses of testosterone were associated with significant increases in desire (300 μg per day, P<0.001; 150 μg per day, P=0.04) and decreases in distress (300 μg per day, P<0.001; 150 μg per day, P=0.04). The rate of androgenic adverse events - primarily unwanted hair growth - was higher in the group receiving 300 μg of testosterone per day than in the placebo group (30.0% vs. 23.1%). Breast cancer was diagnosed in four women who received testosterone (as compared with none who received placebo); one of the four received the diagnosis in the first 4 months of the study period, and one, in retrospect, had symptoms before undergoing randomization. CONCLUSIONS In postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 μg of testosterone per day resulted in a modest but meaningful improvement in sexual function. The long-term effects of testosterone, including effects on the breast, remain uncertain. (ClinicalTrials.gov number, NCT00131495.) |
| CC : | 002B01 |
| FD : | Testostérone; Hormone stéroïde sexuelle; Libido; Postménopause; Femelle; Femme; Adulte; Oestrogène; Médecine |
| FG : | Homme; Androgène |
| ED : | Testosterone; Sex steroid hormone; Libido; Postmenopause; Female; Woman; Adult; Estrogen; Medicine |
| EG : | Human; Androgen |
| SD : | Testosterona; Hormona esteroide sexual; Líbido; Postmenopausia; Hembra; Mujer; Adulto; Estrógeno; Medicina |
| LO : | INIST-6013.354000183921350050 |
| ID : | 08-0528793 |
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Davis</name><affiliation><inist:fA14 i1="01"><s1>Women's Health Program, Monash University, Alfred Hospital</s1><s2>Prahran</s2><s3>AUS</s3><sZ>1 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Moreau, Michele" sort="Moreau, Michele" uniqKey="Moreau M" first="Michele" last="Moreau">Michele Moreau</name><affiliation><inist:fA14 i1="02"><s1>Centre d'Etude Clinique</s1><s2>Montreal</s2><s3>CAN</s3><sZ>2 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Kroll, Robin" sort="Kroll, Robin" uniqKey="Kroll R" first="Robin" last="Kroll">Robin Kroll</name><affiliation><inist:fA14 i1="03"><s1>Women's Clinical Research Center and the Menopause Center of Seattle</s1><s2>Seattle</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Bouchard, Celine" sort="Bouchard, Celine" uniqKey="Bouchard C" first="Céline" last="Bouchard">Céline Bouchard</name><affiliation><inist:fA14 i1="04"><s1>Université Laval</s1><s2>Quebec, QC</s2><s3>CAN</s3><sZ>4 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Panay, Nick" sort="Panay, Nick" uniqKey="Panay N" first="Nick" last="Panay">Nick Panay</name><affiliation><inist:fA14 i1="05"><s1>Queen Charlotte's and Chelsea Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>5 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Gass, Margery" sort="Gass, Margery" uniqKey="Gass M" first="Margery" last="Gass">Margery Gass</name><affiliation><inist:fA14 i1="06"><s1>University of Cincinnati College of Medicine</s1><s2>Cincinnati</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Braunstein, Glenn D" sort="Braunstein, Glenn D" uniqKey="Braunstein G" first="Glenn D." last="Braunstein">Glenn D. 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Davis</name><affiliation><inist:fA14 i1="01"><s1>Women's Health Program, Monash University, Alfred Hospital</s1><s2>Prahran</s2><s3>AUS</s3><sZ>1 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Moreau, Michele" sort="Moreau, Michele" uniqKey="Moreau M" first="Michele" last="Moreau">Michele Moreau</name><affiliation><inist:fA14 i1="02"><s1>Centre d'Etude Clinique</s1><s2>Montreal</s2><s3>CAN</s3><sZ>2 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Kroll, Robin" sort="Kroll, Robin" uniqKey="Kroll R" first="Robin" last="Kroll">Robin Kroll</name><affiliation><inist:fA14 i1="03"><s1>Women's Clinical Research Center and the Menopause Center of Seattle</s1><s2>Seattle</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Bouchard, Celine" sort="Bouchard, Celine" uniqKey="Bouchard C" first="Céline" last="Bouchard">Céline Bouchard</name><affiliation><inist:fA14 i1="04"><s1>Université Laval</s1><s2>Quebec, QC</s2><s3>CAN</s3><sZ>4 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Panay, Nick" sort="Panay, Nick" uniqKey="Panay N" first="Nick" last="Panay">Nick Panay</name><affiliation><inist:fA14 i1="05"><s1>Queen Charlotte's and Chelsea Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>5 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Gass, Margery" sort="Gass, Margery" uniqKey="Gass M" first="Margery" last="Gass">Margery Gass</name><affiliation><inist:fA14 i1="06"><s1>University of Cincinnati College of Medicine</s1><s2>Cincinnati</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Braunstein, Glenn D" sort="Braunstein, Glenn D" uniqKey="Braunstein G" first="Glenn D." last="Braunstein">Glenn D. Braunstein</name><affiliation><inist:fA14 i1="07"><s1>Cedars-Sinai Medical Center</s1><s2>Los Angeles</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Linden Hirschberg, Angelica" sort="Linden Hirschberg, Angelica" uniqKey="Linden Hirschberg A" first="Angelica" last="Linden Hirschberg">Angelica Linden Hirschberg</name><affiliation><inist:fA14 i1="08"><s1>Karolinska University Hospital</s1><s2>Stockholm</s2><s3>SWE</s3><sZ>8 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Rodenberg, Cynthia" sort="Rodenberg, Cynthia" uniqKey="Rodenberg C" first="Cynthia" last="Rodenberg">Cynthia Rodenberg</name><affiliation><inist:fA14 i1="09"><s1>Procter & Gamble Pharmaceuticals</s1><s2>Mason, OH</s2><s3>USA</s3><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Pack, Simon" sort="Pack, Simon" uniqKey="Pack S" first="Simon" last="Pack">Simon Pack</name><affiliation><inist:fA14 i1="09"><s1>Procter & Gamble Pharmaceuticals</s1><s2>Mason, OH</s2><s3>USA</s3><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Koch, Helga" sort="Koch, Helga" uniqKey="Koch H" first="Helga" last="Koch">Helga Koch</name><affiliation><inist:fA14 i1="09"><s1>Procter & Gamble Pharmaceuticals</s1><s2>Mason, OH</s2><s3>USA</s3><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Moufarege, Alain" sort="Moufarege, Alain" uniqKey="Moufarege A" first="Alain" last="Moufarege">Alain Moufarege</name><affiliation><inist:fA14 i1="10"><s1>Debiopharm Group</s1><s2>Charenton-le-Pont</s2><s3>FRA</s3><sZ>12 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Studd, John" sort="Studd, John" uniqKey="Studd J" first="John" last="Studd">John Studd</name><affiliation><inist:fA14 i1="11"><s1>Chelsea and Westminster Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>13 aut.</sZ></inist:fA14></affiliation></author></analytic><series><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Estrogen</term><term>Female</term><term>Libido</term><term>Medicine</term><term>Postmenopause</term><term>Sex steroid hormone</term><term>Testosterone</term><term>Woman</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Testostérone</term><term>Hormone stéroïde sexuelle</term><term>Libido</term><term>Postménopause</term><term>Femelle</term><term>Femme</term><term>Adulte</term><term>Oestrogène</term><term>Médecine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND The efficacy and safety of testosterone treatment for hypoactive sexual desire disorder in postmenopausal women not receiving estrogen therapy are unknown. METHODS We conducted a double-blind, placebo-controlled, 52-week trial in which 814 women with hypoactive sexual desire disorder were randomly assigned to receive a patch delivering 150 or 300 μg of testosterone per day or placebo. Efficacy was measured to week 24; safety was evaluated over a period of 52 weeks, with a subgroup of participants followed for an additional year. The primary end point was the change from baseline to week 24 in the 4-week frequency of satisfying sexual episodes. RESULTS At 24 weeks, the increase in the 4-week frequency of satisfying sexual episodes was significantly greater in the group receiving 300 μg of testosterone per day than in the placebo group (an increase of 2.1 episodes vs. 0.7, P<0.001) but not in the group receiving 150 μg per day (1.2 episodes, P=0.11). As compared with placebo, both doses of testosterone were associated with significant increases in desire (300 μg per day, P<0.001; 150 μg per day, P=0.04) and decreases in distress (300 μg per day, P<0.001; 150 μg per day, P=0.04). The rate of androgenic adverse events - primarily unwanted hair growth - was higher in the group receiving 300 μg of testosterone per day than in the placebo group (30.0% vs. 23.1%). Breast cancer was diagnosed in four women who received testosterone (as compared with none who received placebo); one of the four received the diagnosis in the first 4 months of the study period, and one, in retrospect, had symptoms before undergoing randomization. CONCLUSIONS In postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 μg of testosterone per day resulted in a modest but meaningful improvement in sexual function. The long-term effects of testosterone, including effects on the breast, remain uncertain. (ClinicalTrials.gov number, NCT00131495.)</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0028-4793</s0></fA01><fA02 i1="01"><s0>NEJMAG</s0></fA02><fA03 i2="1"><s0>N. Engl. j. med.</s0></fA03><fA05><s2>359</s2></fA05><fA06><s2>19</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Testosterone for Low Libido in Postmenopausal Women Not Taking Estrogen</s1></fA08><fA11 i1="01" i2="1"><s1>DAVIS (Susan R.)</s1></fA11><fA11 i1="02" i2="1"><s1>MOREAU (Michele)</s1></fA11><fA11 i1="03" i2="1"><s1>KROLL (Robin)</s1></fA11><fA11 i1="04" i2="1"><s1>BOUCHARD (Céline)</s1></fA11><fA11 i1="05" i2="1"><s1>PANAY (Nick)</s1></fA11><fA11 i1="06" i2="1"><s1>GASS (Margery)</s1></fA11><fA11 i1="07" i2="1"><s1>BRAUNSTEIN (Glenn D.)</s1></fA11><fA11 i1="08" i2="1"><s1>LINDEN HIRSCHBERG (Angelica)</s1></fA11><fA11 i1="09" i2="1"><s1>RODENBERG (Cynthia)</s1></fA11><fA11 i1="10" i2="1"><s1>PACK (Simon)</s1></fA11><fA11 i1="11" i2="1"><s1>KOCH (Helga)</s1></fA11><fA11 i1="12" i2="1"><s1>MOUFAREGE (Alain)</s1></fA11><fA11 i1="13" i2="1"><s1>STUDD (John)</s1></fA11><fA14 i1="01"><s1>Women's Health Program, Monash University, Alfred Hospital</s1><s2>Prahran</s2><s3>AUS</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Centre d'Etude Clinique</s1><s2>Montreal</s2><s3>CAN</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Women's Clinical Research Center and the Menopause Center of Seattle</s1><s2>Seattle</s2><s3>USA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Université Laval</s1><s2>Quebec, QC</s2><s3>CAN</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Queen Charlotte's and Chelsea Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>University of Cincinnati College of Medicine</s1><s2>Cincinnati</s2><s3>USA</s3><sZ>6 aut.</sZ></fA14><fA14 i1="07"><s1>Cedars-Sinai Medical Center</s1><s2>Los Angeles</s2><s3>USA</s3><sZ>7 aut.</sZ></fA14><fA14 i1="08"><s1>Karolinska University Hospital</s1><s2>Stockholm</s2><s3>SWE</s3><sZ>8 aut.</sZ></fA14><fA14 i1="09"><s1>Procter & Gamble Pharmaceuticals</s1><s2>Mason, OH</s2><s3>USA</s3><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></fA14><fA14 i1="10"><s1>Debiopharm Group</s1><s2>Charenton-le-Pont</s2><s3>FRA</s3><sZ>12 aut.</sZ></fA14><fA14 i1="11"><s1>Chelsea and Westminster Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>13 aut.</sZ></fA14><fA17 i1="01" i2="1"><s1>APHRODITE Study Team</s1><s3>INC</s3></fA17><fA20><s1>2005-2017</s1></fA20><fA21><s1>2008</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>6013</s2><s5>354000183921350050</s5></fA43><fA44><s0>0000</s0><s1>© 2008 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>44 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>08-0528793</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>The New England journal of medicine</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>BACKGROUND The efficacy and safety of testosterone treatment for hypoactive sexual desire disorder in postmenopausal women not receiving estrogen therapy are unknown. METHODS We conducted a double-blind, placebo-controlled, 52-week trial in which 814 women with hypoactive sexual desire disorder were randomly assigned to receive a patch delivering 150 or 300 μg of testosterone per day or placebo. Efficacy was measured to week 24; safety was evaluated over a period of 52 weeks, with a subgroup of participants followed for an additional year. The primary end point was the change from baseline to week 24 in the 4-week frequency of satisfying sexual episodes. RESULTS At 24 weeks, the increase in the 4-week frequency of satisfying sexual episodes was significantly greater in the group receiving 300 μg of testosterone per day than in the placebo group (an increase of 2.1 episodes vs. 0.7, P<0.001) but not in the group receiving 150 μg per day (1.2 episodes, P=0.11). As compared with placebo, both doses of testosterone were associated with significant increases in desire (300 μg per day, P<0.001; 150 μg per day, P=0.04) and decreases in distress (300 μg per day, P<0.001; 150 μg per day, P=0.04). The rate of androgenic adverse events - primarily unwanted hair growth - was higher in the group receiving 300 μg of testosterone per day than in the placebo group (30.0% vs. 23.1%). Breast cancer was diagnosed in four women who received testosterone (as compared with none who received placebo); one of the four received the diagnosis in the first 4 months of the study period, and one, in retrospect, had symptoms before undergoing randomization. CONCLUSIONS In postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 μg of testosterone per day resulted in a modest but meaningful improvement in sexual function. The long-term effects of testosterone, including effects on the breast, remain uncertain. (ClinicalTrials.gov number, NCT00131495.)</s0></fC01><fC02 i1="01" i2="X"><s0>002B01</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Testostérone</s0><s2>NK</s2><s2>FR</s2><s5>02</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Testosterone</s0><s2>NK</s2><s2>FR</s2><s5>02</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Testosterona</s0><s2>NK</s2><s2>FR</s2><s5>02</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Hormone stéroïde sexuelle</s0><s5>03</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Sex steroid hormone</s0><s5>03</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Hormona esteroide sexual</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Libido</s0><s5>05</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Libido</s0><s5>05</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Líbido</s0><s5>05</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Postménopause</s0><s5>06</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Postmenopause</s0><s5>06</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Postmenopausia</s0><s5>06</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Femelle</s0><s5>08</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Female</s0><s5>08</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Hembra</s0><s5>08</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Femme</s0><s5>09</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Woman</s0><s5>09</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Mujer</s0><s5>09</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Adulte</s0><s5>12</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Adult</s0><s5>12</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Adulto</s0><s5>12</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Oestrogène</s0><s5>14</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Estrogen</s0><s5>14</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Estrógeno</s0><s5>14</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Médecine</s0><s5>15</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>Medicine</s0><s5>15</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Medicina</s0><s5>15</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Homme</s0></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Human</s0></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Hombre</s0></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Androgène</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Androgen</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Andrógeno</s0><s5>37</s5></fC07><fN21><s1>350</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard><server><NO>PASCAL 08-0528793 INIST</NO><ET>Testosterone for Low Libido in Postmenopausal Women Not Taking Estrogen</ET><AU>DAVIS (Susan R.); MOREAU (Michele); KROLL (Robin); BOUCHARD (Céline); PANAY (Nick); GASS (Margery); BRAUNSTEIN (Glenn D.); LINDEN HIRSCHBERG (Angelica); RODENBERG (Cynthia); PACK (Simon); KOCH (Helga); MOUFAREGE (Alain); STUDD (John)</AU><AF>Women's Health Program, Monash University, Alfred Hospital/Prahran/Australie (1 aut.); Centre d'Etude Clinique/Montreal/Canada (2 aut.); Women's Clinical Research Center and the Menopause Center of Seattle/Seattle/Etats-Unis (3 aut.); Université Laval/Quebec, QC/Canada (4 aut.); Queen Charlotte's and Chelsea Hospital/London/Royaume-Uni (5 aut.); University of Cincinnati College of Medicine/Cincinnati/Etats-Unis (6 aut.); Cedars-Sinai Medical Center/Los Angeles/Etats-Unis (7 aut.); Karolinska University Hospital/Stockholm/Suède (8 aut.); Procter & Gamble Pharmaceuticals/Mason, OH/Etats-Unis (9 aut., 10 aut., 11 aut.); Debiopharm Group/Charenton-le-Pont/France (12 aut.); Chelsea and Westminster Hospital/London/Royaume-Uni (13 aut.)</AF><DT>Publication en série; Niveau analytique</DT><SO>The New England journal of medicine; ISSN 0028-4793; Coden NEJMAG; Etats-Unis; Da. 2008; Vol. 359; No. 19; Pp. 2005-2017; Bibl. 44 ref.</SO><LA>Anglais</LA><EA>BACKGROUND The efficacy and safety of testosterone treatment for hypoactive sexual desire disorder in postmenopausal women not receiving estrogen therapy are unknown. METHODS We conducted a double-blind, placebo-controlled, 52-week trial in which 814 women with hypoactive sexual desire disorder were randomly assigned to receive a patch delivering 150 or 300 μg of testosterone per day or placebo. Efficacy was measured to week 24; safety was evaluated over a period of 52 weeks, with a subgroup of participants followed for an additional year. The primary end point was the change from baseline to week 24 in the 4-week frequency of satisfying sexual episodes. RESULTS At 24 weeks, the increase in the 4-week frequency of satisfying sexual episodes was significantly greater in the group receiving 300 μg of testosterone per day than in the placebo group (an increase of 2.1 episodes vs. 0.7, P<0.001) but not in the group receiving 150 μg per day (1.2 episodes, P=0.11). As compared with placebo, both doses of testosterone were associated with significant increases in desire (300 μg per day, P<0.001; 150 μg per day, P=0.04) and decreases in distress (300 μg per day, P<0.001; 150 μg per day, P=0.04). The rate of androgenic adverse events - primarily unwanted hair growth - was higher in the group receiving 300 μg of testosterone per day than in the placebo group (30.0% vs. 23.1%). Breast cancer was diagnosed in four women who received testosterone (as compared with none who received placebo); one of the four received the diagnosis in the first 4 months of the study period, and one, in retrospect, had symptoms before undergoing randomization. CONCLUSIONS In postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 μg of testosterone per day resulted in a modest but meaningful improvement in sexual function. The long-term effects of testosterone, including effects on the breast, remain uncertain. (ClinicalTrials.gov number, NCT00131495.)</EA><CC>002B01</CC><FD>Testostérone; Hormone stéroïde sexuelle; Libido; Postménopause; Femelle; Femme; Adulte; Oestrogène; Médecine</FD><FG>Homme; Androgène</FG><ED>Testosterone; Sex steroid hormone; Libido; Postmenopause; Female; Woman; Adult; Estrogen; Medicine</ED><EG>Human; Androgen</EG><SD>Testosterona; Hormona esteroide sexual; Líbido; Postmenopausia; Hembra; Mujer; Adulto; Estrógeno; Medicina</SD><LO>INIST-6013.354000183921350050</LO><ID>08-0528793</ID></server></inist></record>Pour manipuler ce document sous Unix (Dilib)
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