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The Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind Crossover Study
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.
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.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Start Date
April 1, 2004
Primary Completion Date
May 1, 2007
Completion Date
October 1, 2007
Last Updated
July 13, 2016
150
ACTUAL participants
therapeutic testosterone
DRUG
placebo
OTHER
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07471685