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Home > "L" Clinical Trials Conditions > Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors  Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors
Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors
For Condition: sexuality and reproductive issues,unspecified adult solid tumor, protocol specific,sexual dysfunction and infertility
Status: Not yet recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: The hormonetestosterone may improve the libido (sex drive) in women. It is not yet known whether testosterone is effective in improving libido in female cancer survivors. PURPOSE: Randomizedphase III trial to study the effectiveness of low-dose testosterone in improving libido in postmenopausal cancer survivors.
Details: OBJECTIVES: Primary - Determine the efficacy of low-dose testosterone, in terms of average intra-patient change in libido, in postmenopausal female cancer survivors with a decreased libido. Secondary - Determine the toxic effects of this drug in these patients. - Determine the levels of estrogen and testosterone and SGOT in patients reporting a decreased libido before and after treatment with this drug. - Determine whether increasing libido significantly positively affects pleasure from sexual activity in patients treated with this drug. - Determine the effect of this drug on vitality, general quality of life, and overall mood in these patients. OUTLINE: This is a double-blind, placebo-controlled, randomized, crossover, multicenter study. Patients are stratified according to antidepressant medication use (yes vs no), age (under 50 vs 50 to 60 vs 61 to 70 vs over 70), tamoxifen or other selective estrogen receptor modulator use (yes vs no), and ovarian status (in place [natural menopause or hysterectomy] vs not in place [bilateral oophorectomy]). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive topical testosterone once daily for 4 weeks. - Arm II: Patients receive a topical placebo once daily for 4 weeks. After 4 weeks, patients cross over to the other treatment arm. Changes in sexual functioning, mood states, and medical outcome vitality are assessed at baseline and then at the end of weeks 4 and 8. PROJECTED ACCRUAL: A total of 140 patients (70 per treatment arm) will be accrued for this study within 14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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 - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - See Menopausal status Sex - Female Menopausal status - Postmenopausal, defined as the following: - Absence of a period for at least 12 months (naturally, surgically, or treatment-induced) Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - 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 depression requiring treatment PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - No concurrent dehydroepiandrosterone (DHEA) Radiotherapy - Not specified Surgery - No prior major pelvic surgery resulting in anatomical changes to the vaginal anatomy - Prior hysterectomy allowed Other - Concurrent low-dose 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 - No other concurrent treatment for decreased libido
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DebraBarton, , Mayo Clinic Cancer Center
Additional Information:
Study ID Numbers: CDR0000349426; NCCTG-N02C3
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075855
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. BMS-214662 in Treating Patients With Solid Tumors
2. Combination Chemotherapy In Treating Patients With Metastatic or Unresectable Solid Tumors
3. Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
4. Oxaliplatin and Gemcitabine in Treating Patients With Advanced Cancer
5. BMS-247550 Plus Carboplatin in Treating Patients With Recurrent or Refractory Solid Tumors
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Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors
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