Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors
- Conditions
- Cancer SurvivorSexual DysfunctionSexuality and Reproductive IssuesUnspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Other: placebo
- Registration Number
- NCT00075855
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: The hormone testosterone 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: This randomized phase III trial is studying how well low-dose testosterone works to improve libido in postmenopausal cancer survivors.
- Detailed Description
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.
Patients who continue or restart testosterone cream after the 8-week study period are followed at 6 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description testosterone therapeutic testosterone Patients receive topical testosterone 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. Patients who continue or restart testosterone cream after the 8-week study period are followed at 6 months. placebo placebo 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. Patients who continue or restart testosterone cream after the 8-week study period are followed at 6 months.
- Primary Outcome Measures
Name Time Method Overall mood Up to 6 months
- Secondary Outcome Measures
Name Time Method overall vitality Up to 6 months quality of life Up to 6 months
Trial Locations
- Locations (16)
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
Medcenter One Health System
🇺🇸Bismarck, North Dakota, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States