Testosterone for Low Libido in Postmenopausal Women Not Taking Estrogen
Identifieur interne : 002E68 ( PascalFrancis/Curation ); précédent : 002E67; suivant : 002E69Testosterone for Low Libido in Postmenopausal Women Not Taking Estrogen
Auteurs : Susan R. Davis [Australie] ; Michele Moreau [Canada] ; Robin Kroll [États-Unis] ; Céline Bouchard [Canada] ; Nick Panay [Royaume-Uni] ; Margery Gass [États-Unis] ; Glenn D. Braunstein [États-Unis] ; Angelica Linden Hirschberg [Suède] ; Cynthia Rodenberg [États-Unis] ; Simon Pack [États-Unis] ; Helga Koch [États-Unis] ; Alain Moufarege [France] ; John Studd [Royaume-Uni]Source :
- The New England journal of medicine [ 0028-4793 ] ; 2008.
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- Wicri :
English descriptors
- KwdEn :
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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<author><name sortKey="Gass, Margery" sort="Gass, Margery" uniqKey="Gass M" first="Margery" last="Gass">Margery Gass</name>
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<author><name sortKey="Braunstein, Glenn D" sort="Braunstein, Glenn D" uniqKey="Braunstein G" first="Glenn D." last="Braunstein">Glenn D. Braunstein</name>
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<author><name sortKey="Linden Hirschberg, Angelica" sort="Linden Hirschberg, Angelica" uniqKey="Linden Hirschberg A" first="Angelica" last="Linden Hirschberg">Angelica Linden Hirschberg</name>
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<author><name sortKey="Rodenberg, Cynthia" sort="Rodenberg, Cynthia" uniqKey="Rodenberg C" first="Cynthia" last="Rodenberg">Cynthia Rodenberg</name>
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<author><name sortKey="Pack, Simon" sort="Pack, Simon" uniqKey="Pack S" first="Simon" last="Pack">Simon Pack</name>
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<author><name sortKey="Koch, Helga" sort="Koch, Helga" uniqKey="Koch H" first="Helga" last="Koch">Helga Koch</name>
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<author><name sortKey="Moufarege, Alain" sort="Moufarege, Alain" uniqKey="Moufarege A" first="Alain" last="Moufarege">Alain Moufarege</name>
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<s2>Charenton-le-Pont</s2>
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<sZ>12 aut.</sZ>
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<country>France</country>
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<author><name sortKey="Studd, John" sort="Studd, John" uniqKey="Studd J" first="John" last="Studd">John Studd</name>
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<s2>London</s2>
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<sZ>13 aut.</sZ>
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<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>
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<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>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Femme</term>
<term>Adulte</term>
<term>Médecine</term>
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<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>
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<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>
</inist>
</record>
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