© The Author 2007. Published by Oxford University Press.
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Randomized Controlled Trial to Evaluate Transdermal Testosterone in Female Cancer Survivors With Decreased Libido; North Central Cancer Treatment Group Protocol N02C3
Affiliations of authors: Departments of Medical Oncology (DLB, CLL), Cancer Center Statistics (JAS, PJA), and Endocrinology (PCC), Mayo Clinic and Mayo Foundation, Rochester, MN; Siouxland Hematology–Oncology Associates, Sioux City, IA (DBW); Duluth Community Clinical Oncology Program [CCOP], Duluth, MN (RJD); Michigan Cancer Research Consortium, Ann Arbor, MI (EPB); Geisinger Clinic & Medical Center CCOP, Danville, PA (AMB); Cancer Center, Altru Health Systems, Grand Forks, ND (WLD); Metro-Minnesota CCOP, St Louis Park, MN (TL); Upstate Carolina CCOP, Spartanburg, SC (JDB)
Correspondence to: Debra L. Barton, RN, PhD, AOCN, Department of Oncology, Mayo Clinic College of Medicine, Mayo Clinic, 200 First St SW, Rochester, MN 55905 (e-mail: barton.debra{at}mayo.edu).
Background: 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.
Methods: 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.
Results: 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.
Conclusion: Increased testosterone level did not translate into improved libido, possibly because women on this study were estrogen depleted.
| CONTEXT AND CAVEATS Prior knowledge Female cancer patients often experience decreased libido, and therapy with transdermal testosterone has been associated with increased libido among estrogen-replete women who report low libido. Study design Randomized placebo-controlled phase III trial of transdermal testosterone using a crossover design among postmenopausal female cancer survivors who did not receive estrogen supplementation. Contribution Although serum testosterone levels increased during treatment, no change in libido was observed over placebo. Implications Increased levels of testosterone did not improve libido among women who were estrogen depleted. Limitations The study was of libido only. Other variables contributing to sexual function were not addressed.
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Manuscript received September 18, 2006; revised February 2, 2007; accepted March 19, 2007.
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J Natl Cancer Inst 2008 100: 1482.
J Natl Cancer Inst 2007 99: 659-661.
J Natl Cancer Inst 2007 99: 657.
J Natl Cancer Inst 2007 99: 657.
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