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NCT01573442 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 3
Development phase
227
Enrollment target

NCT01573442: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.

NCT01573442 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 227 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01573442, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 3
Development phase
227 participants
Enrollment target

Study 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.

Primary Outcome

The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and month 3 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

Interventions

  • OTHER placebo
  • DRUG testosterone

Trial Details

FieldValue
Enrollment Target 227 participants
Start Date 2013-09-10
Est. Completion 2019-09-01
Phase Phase 3

What the finished NCT01573442 record still lists

NCT01573442 is an interventional study that assigns participants to a tested intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT01573442 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01573442 about?

NCT01573442 is a clinical study titled "Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment". 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 inhi...

What is the current status of trial NCT01573442?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 227 participants. The study started on 2013-09-10. Estimated completion is 2019-09-01.

What interventions are being tested in trial NCT01573442?

The interventions under investigation include: placebo (OTHER), testosterone (DRUG).

Who is sponsoring clinical trial NCT01573442?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01573442's enrollment target sits among peer trials

227 1310th of 2000 higher than 691 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01573442, the US trial registry maintained by the National Library of Medicine. NCT01573442 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.