150 Participants Needed

Testosterone Therapy for Low Testosterone

(PATH Trial)

RB
AD
HK
LC
GH
AG
Overseen ByAnna Goldman, MD
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Brigham and Women's Hospital
Must be taking: Opioid analgesics
Prior Safety DataThis treatment has passed at least one previous human 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

RR

Robert R Edwards, PhD

Principal Investigator

Brigham and Women's Hospital

SB

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

I have been using opioid painkillers for at least 6 months.
Ability and willingness to provide informed consent
I have long-term back pain not caused by cancer.
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Exclusion Criteria

I have not used testosterone in the last 6 months.
Your blood has more red blood cells than it should.
Your prostate-specific antigen (PSA) level is higher than 4 ng/mL if you are Caucasian, or higher than 3 ng/mL if you are African-American.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive testosterone or placebo for 6 months to evaluate improvements in pain perception, sexual function, fatigue, and quality of life

6 months
Baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Placebo
  • Testosterone cypionate
  • Testosterone Undecanoate 250 MG/ML
Trial OverviewThe 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.
Participant Groups
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.

Testosterone cypionate is already approved in United States for the following indications:

🇺🇸
Approved in United States as Depo-Testosterone for:
  • Primary hypogonadism
  • Hypogonadotropic hypogonadism
  • Delayed puberty

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Findings from Research

Testosterone undecanoate (TU) is a long-acting injectable testosterone replacement therapy that can be administered only four times a year, providing stable testosterone levels with an excellent safety profile.
Long-term studies, including data from patients treated for over 8 years, show that TU is effective and safe, with no serious side effects reported, making it a desirable option for hypogonadal men.
Testosterone undecanoate in the treatment of male hypogonadism.Edelstein, D., Basaria, S.[2014]
Testosterone therapy (TT) can effectively alleviate symptoms of testosterone deficiency, such as low energy and libido, by restoring serum testosterone levels to the normal range.
Testosterone undecanoate (TU), available in both oral and injectable forms, offers a convenient option for patients, potentially improving compliance, while injectable forms remain the most cost-effective initial treatment for most patients.
Safety Aspects and Rational Use of Testosterone Undecanoate in the Treatment of Testosterone Deficiency: Clinical Insights.Campbell, K., Muthigi, A., Ghomeshi, A., et al.[2023]
Male hypogonadism affects a significant portion of the male population (10-30%) and is often not adequately recognized or treated, highlighting the need for effective treatment options.
JATENZO and TLANDO are the first oral testosterone formulations approved by the FDA, utilizing a unique delivery system that allows for safe absorption without causing liver dysfunction, addressing limitations of traditional testosterone replacement therapies.
Testosterone Replacement Therapy: A Narrative Review with a Focus on New Oral Formulations.Bhat, SZ., Dobs, AS.[2023]

References

Testosterone undecanoate in the treatment of male hypogonadism. [2014]
Safety Aspects and Rational Use of Testosterone Undecanoate in the Treatment of Testosterone Deficiency: Clinical Insights. [2023]
Testosterone Replacement Therapy: A Narrative Review with a Focus on New Oral Formulations. [2023]
Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. [2023]
Clinical efficacy of testosterone undecanoate in male hypogonadism. [2019]
Testosterone depot injection in male hypogonadism: a critical appraisal. [2021]
A ten-year safety study of the oral androgen testosterone undecanoate. [2014]
Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis. [2022]
Optimal methotrexate dose is associated with better clinical outcomes than non-optimal dose in daily practice: results from the ESPOIR early arthritis cohort. [2022]
[Guidelines for prescribing and monitoring biologic therapies in juvenile idiopathic arthritis]. [2013]
Methotrexate as the "anchor drug" for the treatment of early rheumatoid arthritis. [2022]
The methotrexate therapeutic response in rheumatoid arthritis. [2013]