Testosterone Therapy for Low Testosterone
(PATH Trial)
Trial Summary
What is the purpose of this trial?
The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, fatigue, and quality of life when compared with placebo in men with chronic spinal pain treated with opioids who have opioid-induced hypogonadism (low testosterone).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must not have used testosterone in the past 6 months.
What data supports the effectiveness of the drug Testosterone undecanoate for low testosterone?
Research shows that Testosterone undecanoate is effective in treating male hypogonadism (a condition where the body doesn't produce enough testosterone) by significantly increasing plasma testosterone levels, improving symptoms like decreased energy and libido, and providing a convenient oral option that may enhance patient compliance.12345
Is testosterone therapy generally safe for humans?
Testosterone therapy, particularly with testosterone undecanoate, has been shown to have a good safety profile in humans. Long-term studies indicate no significant adverse effects on liver function, lipid profiles, or prostate health, and it avoids the 'roller coaster' effects of traditional testosterone injections.14567
What makes testosterone cypionate and testosterone undecanoate unique for treating low testosterone?
Testosterone cypionate and testosterone undecanoate are unique because they offer different administration routes and dosing schedules compared to other testosterone therapies. Testosterone cypionate is typically injected every 1-2 weeks, while testosterone undecanoate can be administered less frequently, potentially improving convenience and adherence for patients.89101112
Research Team
Robert R Edwards, PhD
Principal Investigator
Brigham and Women's Hospital
Shehzad Basaria, MD
Principal Investigator
Brigham and Women's Hospital
Eligibility Criteria
This trial is for men over 18 with chronic back pain treated with opioids, leading to low testosterone levels. They must have been on opioid painkillers for at least six months and be willing to consent. Men with prostate or breast cancer, certain mental health conditions, recent heart issues, severe kidney or liver disease, or specific metallic implants cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive testosterone or placebo for 6 months to evaluate improvements in pain perception, sexual function, fatigue, and quality of life
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- Testosterone cypionate
- Testosterone Undecanoate 250 MG/ML
Testosterone cypionate is already approved in United States for the following indications:
- Primary hypogonadism
- Hypogonadotropic hypogonadism
- Delayed puberty
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor