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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Alliance for Clinical Trials in Oncology

Current Primary Outcome:

  • Intra-patient change in joint pain at 3 months from baseline as measured by item #3 (average) of the Brief Pain Inventory [ Time Frame: Up to 3 months ]
  • Proportion of women with changes in pain at least 10 points on a converted 0-100 scale at 3 months from baseline [ Time Frame: Up to 3 months ]
    Proportion of women with an improvement (reduced pain) of at least 10 points (on a converted 0-100 scale)
  • The intra-patient change in joint pain at 6 months from baseline as measured by item #3 (average) of the Brief Pain Inventory for aromatase inhibitor arthralgias (BPI-AIA). [ Time Frame: Up to 6 months ]
  • The intra-patient changes in joint pain at each month from baseline as measured by the BPI-AIA. [ Time Frame: Up to 6 months ]


Original Primary Outcome: The intra-patient change in joint pain at 3 months from baseline as measured by the Brief Pain Inventory for aromatase-inhibitor arthralgias (BPI-AIA)

Current Secondary Outcome:

  • Incidence of toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) 4.0. [ Time Frame: Up to 6 months ]
  • Alopecia as reported by the patient using CTCAE 4.0 [ Time Frame: Up to 6 months ]
  • Acne as reported by the patient using CTCAE 4.0 [ Time Frame: Up to 6 months ]
  • Hirsutism as reported by the patient using CTCAE 4.0 [ Time Frame: Up to 6 months ]
  • The change of hot flashes during the first two months from baseline as measured by hot flash diary [ Time Frame: Up to 2 months ]
  • The change of libido from baseline as measured by POMS monthly. [ Time Frame: Up to 6 months ]
  • The change of menopause specific quality of life from baseline as measured by MENQOL monthly. [ Time Frame: Up to 6 months ]
  • The intrapatient change in joint pain for each month from baseline as measured by item#1 (worst) of the BPI-AIA. [ Time Frame: Up to 6 months ]
  • The intrapatient change in joint pain for each month from baseline as measured by item#2 (least) of the BPI-AIA. [ Time Frame: Up to 6 months ]
  • The intrapatient change in joint pain for each month from baseline as measured by item#4 (right now) of the BPI-AIA. [ Time Frame: Up to 6 months ]
  • The intrapatient change in joint pain for each month from baseline as measured by item#5 (stiffness) of the BPI-AIA. [ Time Frame: Up to 6 months ]
  • The intrapatient change in activity level (interference of activity) for each month from baseline as measured by item#6 (interference) of the BPI-AIA. [ Time Frame: Up to 6 months ]


Original Secondary Outcome:

  • Safety and tolerability of transdermal testosterone assessed using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 and additional questionnaires, including alopecia, acne, and hirsutism as reported by the patient
  • The intra-patient change in joint pain and its interference of activity for each month from baseline as measured by BPI-AIA
  • The change of hot flashes during the first two months from baseline as measured by hot flash diary
  • The change of libido and menopause-specific quality of life from baseline as measured by MENQOL and POMS monthly


Information By: Alliance for Clinical Trials in Oncology

Dates:
Date Received: April 6, 2012
Date Started: August 2013
Date Completion:
Last Updated: May 24, 2017
Last Verified: May 2017