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

NCT04895306 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Testosterone Cypionate

Weekly intramuscular administration of testosterone at a dose of 3 mg

DRUG

Placebo

Weekly intramuscular administration of Placebo

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Shehzad Basaria, M.D. · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2026-03-27
Completion
2026-03-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04895306 on ClinicalTrials.gov