NCT04895306

Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)

Exploring the Role of Testosterone as a Novel Anti-Nociceptive Agent in Women With Chronic Pain and Opioid Use

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, physical function and quality of life when compared with placebo in women with chronic back pain treated with opioids who have low testosterone.

Detailed description

This single-center, randomized, double-blind, placebo-controlled, parallel-group trial will evaluate pain and quality of life outcomes associated with 3 months of treatment with testosterone or placebo in women aged 60 years or older with chronic non-cancer back pain who are taking opioid analgesics for at least 6 months and have low testosterone.

Conditions

• Pain
• Opioid Use
• Androgen Deficiency
• Back Pain

Interventions

Type	Name	Description
DRUG	Testosterone Cypionate	Weekly intramuscular administration of testosterone at a dose of 3 mg
DRUG	Placebo	Weekly intramuscular administration of Placebo

Timeline

• Start date: 2022-11-15
• Primary completion: 2026-03-27
• Completion: 2026-03-27
• First posted: 2021-05-20
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study