Clinical Trials Directory

Trials / Completed

CompletedNCT01573442

Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment

Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
227 (actual)
Sponsor
Alliance for Clinical Trials in Oncology · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia (joint pain) caused by anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole.

Detailed description

This is a randomized, placebo-controlled, phase III trial evaluating subcutaneous testosterone for the alleviation of aromatase inhibitor induced arthralgia. A parallel group design will be utilized for this two-arm study: subcutaneous testosterone vs. placebo. Patients are stratified according to baseline pain score (5-6 vs. 7-10) and age (\< 50 vs. 50-60 vs. \> 60). The primary objective is to determine whether testosterone will reduce AI-induced arthralgia and associated joint symptoms. The secondary objective is to explore whether testosterone will have an acceptable safety and tolerability profile, with particular reference to androgenic adverse events including acne, hirsutism, and alopecia. Patients are followed up to six months as defined in the protocol.

Conditions

Interventions

TypeNameDescription
DRUGtestosterone10.4 mg
OTHERplacebo

Timeline

Start date
2013-09-10
Primary completion
2018-02-28
Completion
2019-09-01
First posted
2012-04-09
Last updated
2025-01-28
Results posted
2019-06-05

Locations

529 sites across 2 countries: United States, Puerto Rico

Source: ClinicalTrials.gov record NCT01573442. Inclusion in this directory is not an endorsement.