The Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind Crossover Study

Date de début de l'étude : 1 avril 2004

DISEASE CHARACTERISTICS: * History of cancer * No active disease * Currently has a sexual partner * Reports a decrease in sexual desire or libido and would like an intervention for it * Defined as a score of less than 8 on the numerical analogue scale PATIENT CHARACTERISTICS: Age * See Menopausal status Sex * Female Menopausal status * Postmenopausal, defined as the following: * Surgically induced menopause OR absence of a period for at least 12 months (naturally or treatment-induced) Performance status * ECOG 0-1 Hematopoietic * WBC ≥ 2,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * No untreated anemia Hepatic * SGOT ≤ 1.5 times upper limit of normal (ULN) * No known liver disease Renal * Creatinine ≤ 1.5 times ULN * No renal dysfunction Cardiovascular * No coronary artery disease * No congestive heart failure Other * No untreated hypothyroidism * No diabetes * No major depressive disorder requiring treatment PRIOR CONCURRENT THERAPY: Chemotherapy * Concurrent cytotoxic chemotherapy (e.g., tamoxifen or aromatase inhibitors) allowed Endocrine therapy * No prior testosterone * No prior androgen agents for libido * Concurrent selective estrogen receptor modulators allowed * Concurrent vaginal estrogen allowed provided it was initiated ≥ 1 month ago and continued at the same dose during study participation Radiotherapy * Concurrent radiotherapy allowed Surgery * No prior major pelvic surgery resulting in anatomical changes to the vaginal anatomy * Prior hysterectomy allowed Other * Concurrent antidepressants for postmenopausal mood or hot flashes allowed provided patient is on a stable dose that will not change within the next 8 weeks * No concurrent anticoagulants or propanolol * Concurrent anticoagulants for central or peripheral line maintenance (e.g., warfarin 1 mg daily or heparin flushes) allowed * No other concurrent treatment for decreased libido