Davis Susan R, Moreau Michele, Kroll Robin, Bouchard Céline, Panay Nick, Gass Margery, Braunstein Glenn D, Hirschberg Angelica Linden, Rodenberg Cynthia, Pack Simon, Koch Helga, Moufarege Alain, Studd John
Women's Health Program, Monash University, Alfred Hospital, Prahran, Australia.
N Engl J Med. 2008 Nov 6;359(19):2005-17. doi: 10.1056/NEJMoa0707302.
The efficacy and safety of testosterone treatment for hypoactive sexual desire disorder in postmenopausal women not receiving estrogen therapy are unknown.
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 microg 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.
At 24 weeks, the increase in the 4-week frequency of satisfying sexual episodes was significantly greater in the group receiving 300 microg 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 microg per day (1.2 episodes, P=0.11). As compared with placebo, both doses of testosterone were associated with significant increases in desire (300 microg per day, P<0.001; 150 microg per day, P=0.04) and decreases in distress (300 microg per day, P<0.001; 150 microg per day, P=0.04). The rate of androgenic adverse events - primarily unwanted hair growth - was higher in the group receiving 300 microg 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.
In postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 microg 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.)
对于未接受雌激素治疗的绝经后女性，睾酮治疗性欲减退障碍的疗效和安全性尚不清楚。
我们进行了一项双盲、安慰剂对照、为期52周的试验，将814名性欲减退障碍女性随机分配，分别接受每日释放150微克或300微克睾酮的贴片或安慰剂治疗。在第24周时测量疗效；在52周的时间内评估安全性，其中一组参与者还额外随访了一年。主要终点是从基线到第24周时，每4周有满意性活动的频率变化。
在第24周时，每日接受300微克睾酮治疗的组每4周有满意性活动的频率增加显著大于安慰剂组（增加2.1次性活动vs.0.7次，P<0.001），但每日接受150微克睾酮治疗的组无显著差异（增加1.2次性活动，P=0.11）。与安慰剂相比，两种剂量的睾酮均与性欲显著增加（每日300微克，P<0.001；每日150微克，P=0.04）和痛苦感降低（每日300微克，P<0.001；每日150微克，P=0.04）相关。接受每日300微克睾酮治疗的组雄激素相关不良事件发生率——主要为毛发增生——高于安慰剂组（30.0%vs.23.1%）。接受睾酮治疗的4名女性被诊断出患有乳腺癌（接受安慰剂治疗的女性无一人患癌）；其中一名在研究期的前4个月被诊断出，另一名经回顾，在随机分组前就有症状。
在未接受雌激素治疗的绝经后女性中，每日使用释放300微克睾酮的贴片治疗可使性功能有适度但有意义的改善。睾酮的长期影响，包括对乳腺的影响，仍不确定。（临床试验注册号，NCT00131495。）
