Huang Grace, Basaria Shehzad, Travison Thomas G, Ho Matthew H, Davda Maithili, Mazer Norman A, Miciek Renee, Knapp Philip E, Zhang Anqi, Collins Lauren, Ursino Monica, Appleman Erica, Dzekov Connie, Stroh Helene, Ouellette Miranda, Rundell Tyler, Baby Merilyn, Bhatia Narender N, Khorram Omid, Friedman Theodore, Storer Thomas W, Bhasin Shalender
From the 1Section of Endocrinology, Diabetes, and Nutrition, Boston University School of Medicine and Boston Medical Center, Boston, MA; 2Department of Biostatistics, Boston University School of Public Health, Boston, MA; 3Division of Endocrinology, Metabolism, and Molecular Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, CA; and 4Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Harbor-UCLA Medical Center, University of California, Los Angeles, CA.
Menopause. 2014 Jun;21(6):612-23. doi: 10.1097/GME.0000000000000093.
This study aims to determine the dose-dependent effects of testosterone on sexual function, body composition, muscle performance, and physical function in hysterectomized women with or without oophorectomy.
Seventy-one postmenopausal women who previously underwent hysterectomy with or without oophorectomy and had total testosterone levels less than 31 ng/dL or free testosterone levels less than 3.5 pg/mL received a standardized transdermal estradiol regimen during the 12-week run-in period and were randomized to receive weekly intramuscular injections of placebo or 3, 6.25, 12.5, or 25 mg of testosterone enanthate for 24 weeks. Total and free testosterone levels were measured by liquid chromatography-tandem mass spectrometry and equilibrium dialysis, respectively. The primary outcome was change in sexual function measured by the Brief Index of Sexual Functioning for Women. Secondary outcomes included changes in sexual activity, sexual distress, Derogatis Interview for Sexual Functioning, lean body mass, fat mass, muscle strength and power, and physical function.
Seventy-one women were randomized; five groups were similar at baseline. Sixty-two women with analyzable data for the primary outcome were included in the final analysis. The mean on-treatment total testosterone concentrations were 19, 78, 102, 128, and 210 ng/dL in the placebo, 3-mg, 6.25-mg, 12.5-mg, and 25-mg groups, respectively. Changes in composite Brief Index of Sexual Functioning for Women scores, thoughts/desire, arousal, frequency of sexual activity, lean body mass, chest-press power, and loaded stair-climb power were significantly related to increases in free testosterone concentrations; compared with placebo, changes were significantly greater in women assigned to the 25-mg group, but not in women in the lower-dose groups. Sexual activity increased by 2.7 encounters per week in the 25-mg group. The frequency of androgenic adverse events was low.
Testosterone administration in hysterectomized women with or without oophorectomy for 24 weeks was associated with dose and concentration-dependent gains in several domains of sexual function, lean body mass, chest-press power, and loaded stair-climb power. Long-term trials are needed to weigh improvements in these outcomes against potential long-term adverse effects.
本研究旨在确定睾酮对接受或未接受卵巢切除术的子宫切除术后女性的性功能、身体成分、肌肉性能和身体功能的剂量依赖性影响。
71名绝经后女性，她们之前接受过子宫切除术，有或没有接受卵巢切除术，总睾酮水平低于31 ng/dL或游离睾酮水平低于3.5 pg/mL，在12周的导入期接受标准化经皮雌二醇治疗方案，然后随机分组，每周接受一次肌肉注射安慰剂或3、6.25、12.5或25 mg庚酸睾酮，共24周。总睾酮水平和游离睾酮水平分别通过液相色谱 - 串联质谱法和平衡透析法测量。主要结局是通过女性性功能简要指数测量的性功能变化。次要结局包括性活动、性困扰、性功能Derogatis访谈、瘦体重、脂肪量、肌肉力量和功率以及身体功能的变化。
71名女性被随机分组；五组在基线时相似。最终分析纳入了62名有主要结局可分析数据的女性。安慰剂组、3 mg组、6.25 mg组、12.5 mg组和25 mg组治疗期间的平均总睾酮浓度分别为19、78、102、128和210 ng/dL。女性性功能简要指数综合评分、想法/欲望、唤醒、性活动频率、瘦体重、胸推功率和负重爬楼梯功率的变化与游离睾酮浓度的增加显著相关；与安慰剂组相比，25 mg组女性的变化显著更大，但低剂量组女性则不然。25 mg组的性活动每周增加2.7次。雄激素不良事件的发生率较低。
对接受或未接受卵巢切除术的子宫切除术后女性给予睾酮24周，与性功能、瘦体重、胸推功率和负重爬楼梯功率等多个领域的剂量和浓度依赖性改善相关。需要进行长期试验来权衡这些结局的改善与潜在的长期不良影响。
