Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer Survivor
• Sexual Dysfunction
• Sexuality and Reproductive Issues
• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT00075855
• Study type: Interventional
• Source: Alliance for Clinical Trials in Oncology
• Status: Completed
• Phase: Phase 3
• Start date: April 2004
• Completion date: October 2007