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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
All Individual Drugs Already Approved

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 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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,664 Previous Clinical Trials
11,834,836 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
~40 spots leftby Oct 2025
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