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

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.

Timeline

Start

2013-09-10

Primary completion

2018-02-28

Completion

2019-09-01

Outcome

Mixed primary results

registry MEAN Arm II (Placebo): -1.9 (Standard Deviation 2.5) score on a scale NCT01573442 ↗

registry MEAN Arm I (Testosterone): -2.0 (Standard Deviation 2.5) score on a scale NCT01573442 ↗

registry analysis (superiority test); Arm II (Placebo) vs Arm I (Testosterone); p = 0.4952; Wilcoxon (Mann-Whitney) NCT01573442 ↗

registry MEAN Arm II (Placebo): From baseline to month 1: -1.2 (Standard Deviation 2.2) score on a scale NCT01573442 ↗

registry MEAN Arm I (Testosterone): From baseline to month 1: -1.7 (Standard Deviation 2.1) score on a scale NCT01573442 ↗

registry analysis (superiority test); Arm II (Placebo) vs Arm I (Testosterone); p = 0.029; Wilcoxon (Mann-Whitney) NCT01573442 ↗

paper there were no significant differences in average pain or joint stiffness at 3 or 6 months between testosterone and placebo arms. PMID 32372176 ↗

Publications

• Cathcart-Rake E, Novotny P, Leon-Ferre R, Le-Rademacher J, Storrick EM, Adjei AA, Terstriep S, Glaser R, Giuliano A, Mitchell WR, Page S, Austin C, Deming RL, Ferreira MA, Lafky JM, Birrell SN, Loprinzi CL. A randomized, double-blind, placebo-controlled trial of testosterone for treatment of postmenopausal women with aromatase inhibitor-induced arthralgias: Alliance study A221102. Support Care Cancer. 2021 Jan;29(1):387-396. doi: 10.1007/s00520-020-05473-2. Epub 2020 May 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Testosterone	Small molecule	10.4 mg	Subcutaneous

Indications