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Androgen Replacement Therapy

Testosterone Therapy for Low Testosterone (PATH Trial)

Phase 2

Recruiting

Led By Shehzad Basaria, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic non-cancer back pain.

Use of opioid analgesics for at least 6 months

Must not have

Known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or testicular disease)

Use of testosterone within the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, and 6 months

Awards & highlights

Summary

This trial is testing whether testosterone replacement can help improve pain perception, pain tolerance, sexual function, fatigue, and quality of life in men with chronic back pain being treated with opioids who have low testosterone due to their opioid use.

Who is the study for?

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.

What is being tested?

The study tests if testosterone replacement (Testosterone Undecanoate) can better improve pain perception, tolerance, sexual function, fatigue and life quality compared to a placebo in these men.

What are the potential side effects?

Potential side effects of Testosterone Undecanoate include acne, changes in sex drive or performance, hair loss or growth on the body/face and mood swings. More serious risks may involve blood clots and heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have long-term back pain not caused by cancer.

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I have been using opioid painkillers for at least 6 months.

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I have been using opioid painkillers for at least 6 months.

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My testosterone levels are low according to recent tests.

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I am a man aged 18 or older.

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I am a man aged 18 or older.

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I have long-term back pain not caused by cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a diagnosed condition that affects my body's ability to produce sex hormones.

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I have not used testosterone in the last 6 months.

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I have been diagnosed with bipolar disorder or schizophrenia.

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I have a history of prostate or breast cancer.

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I have a lump or hard area in my prostate found during a physical exam.

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I have heart failure that is not well-managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire

Secondary study objectives

Changes in default mode network connectivity

Changes in response to quantitative sensory testing of pain under a mechanical stimulus

Changes in response to quantitative sensory testing of pain under cold stimulus

+3 more

Other study objectives

Changes in Patient's Global Impression of Change (PGIC) scores

Changes in catastrophizing assessed with the Pain Catastrophizing Scale (PCS) questionnaire

Changes in depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TestosteroneExperimental Treatment1 Intervention

Intramuscular injections of testosterone undecanoate 750 mg.

Group II: PlaceboPlacebo Group1 Intervention

Intramuscular injections of placebo.

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,653 Previous Clinical Trials

11,490,885 Total Patients Enrolled

Shehzad Basaria, MDPrincipal InvestigatorBrigham and Women's Hospital

3 Previous Clinical Trials

314 Total Patients Enrolled

Robert R Edwards, PhDPrincipal InvestigatorBrigham and Women's Hospital

2 Previous Clinical Trials

396 Total Patients Enrolled

Media Library

Testosterone cypionate (Androgen Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04798469 — Phase 2

Opioid Use Disorder Research Study Groups: Testosterone, Placebo

Opioid Use Disorder Clinical Trial 2023: Testosterone cypionate Highlights & Side Effects. Trial Name: NCT04798469 — Phase 2

Testosterone cypionate (Androgen Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04798469 — Phase 2

~41 spots leftby Sep 2025

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