Barton Debra L, Wender Donald B, Sloan Jeff A, Dalton Robert J, Balcueva Ernie P, Atherton Pamela J, Bernath Albert M, DeKrey Wanda L, Larson Tim, Bearden James D, Carpenter Paul C, Loprinzi Charles L
Department of Medical Oncology, Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA.
J Natl Cancer Inst. 2007 May 2;99(9):672-9. doi: 10.1093/jnci/djk149.
Decreased libido is one of several changes in sexual function that are often experienced by female cancer patients. Transdermal testosterone therapy has been associated with increased libido among estrogen-replete women who report low libido.
In a phase III randomized, placebo-controlled crossover clinical trial, we evaluated whether transdermal testosterone would increase sexual desire in female cancer survivors. Postmenopausal women with a history of cancer and no current evidence of disease were eligible if they reported a decrease in sexual desire and had a sexual partner. Eligible women were randomly assigned to receive 2% testosterone in Vanicream for a testosterone dose of 10 mg daily or placebo Vanicream for 4 weeks and were then crossed over to the opposite treatment for an additional 4 weeks. The primary endpoint was sexual desire or libido, as measured using the desire subscales of the Changes in Sexual Functioning Questionnaire, as assessed at baseline and at the end of 4 and 8 weeks of treatment. Serum levels of bioavailable testosterone were measured at the same times. All statistical tests were two-sided.
We enrolled 150 women. Women who were on active testosterone cream had higher serum levels of bioavailable testosterone than women on placebo (mean change from baseline, testosterone versus placebo, week 4, 11.57% versus 0%, difference = 11.57%, 95% confidence interval [CI] = 8.49% to 14.65%; week 8, 10.21% versus 0.28%, difference = 9.92%, 95% CI = 5.42% to 14.42%; P<.001 for all). However, the average intrapatient libido change from baseline to weeks 4 and 8 was similar on both arms.
Increased testosterone level did not translate into improved libido, possibly because women on this study were estrogen depleted.
性欲减退是女性癌症患者经常经历的性功能变化之一。经皮睾酮治疗与报告性欲低下的雌激素充足女性的性欲增加有关。
在一项III期随机、安慰剂对照交叉临床试验中，我们评估了经皮睾酮是否会增加女性癌症幸存者的性欲。有癌症病史且目前无疾病证据的绝经后女性，如果报告性欲减退且有性伴侣，则符合条件。符合条件的女性被随机分配接受含2%睾酮的凡立霜，每日睾酮剂量为10毫克，或接受安慰剂凡立霜，为期4周，然后交叉接受相反治疗，再持续4周。主要终点是性欲，使用性功能问卷中欲望分量表进行测量，在基线以及治疗4周和8周结束时进行评估。同时测量血清中生物可利用睾酮的水平。所有统计检验均为双侧检验。
我们招募了150名女性。使用活性睾酮霜的女性血清中生物可利用睾酮水平高于使用安慰剂的女性（从基线的平均变化，睾酮组与安慰剂组，第4周，11.57%对0%，差异=11.57%，95%置信区间[CI]=8.49%至14.65%；第8周，10.21%对0.28%，差异=9.92%，95%CI=5.42%至14.42%；所有P<0.001）。然而，两组患者从基线到第4周和第8周的平均性欲变化相似。
睾酮水平升高并未转化为性欲改善，可能是因为本研究中的女性雌激素缺乏。
