CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 227 enrolled
Drug / intervention
testosterone +1 moredrug
Likely dose
testosterone 10.4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01573442
NCT01573442Phase 3Completed
CompareCT.gov

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

Alliance for Clinical Trials in Oncology·interventional·Posted Apr 9, 2012·Updated Jan 28, 2025

In Brief

A Phase 3 clinical trial evaluating testosterone and placebo for Arthralgia and 4 related conditions. Completed, enrolled 227 participants across 529 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthralgia, Breast Cancer, Hot Flashes, Musculoskeletal Complications, Sexual Dysfunction
CountriesPuerto Rico, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 9, 2012
Enrollment StartSep 10, 2013
Primary CompletionFeb 28, 2018
Study CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 14.2 years ago

Interventions

testosteronedrug

10.4 mg

placeboother