Suspended

Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception in Men With Chronic Pain Syndrome

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What is being tested

Testosterone Gel

+ Placebo Gel

Drug
Who is being recruted

Endocrine System Diseases+4

+ Gonadal Disorders

+ Neurologic Manifestations

Over 18 Years
+29 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorJohns Hopkins University
Last updated: March 31, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

This research is being done to see whether testosterone replacement in men who take opioid-based pain medications and have low testosterone levels will show improvement in pain tolerance, pain perception and quality of life. Some men who take opioid-based medications (narcotics) for pain develop low testosterone levels. Research has shown that low testosterone levels may make a person more sensitive to pain. This means that if a person with a painful condition develops low testosterone level as a result of his pain medications, he might become more sensitive to pain and so may need higher doses of pain medications for pain control. Testosterone is a male hormone that is important for sperm production and the development of male characteristics such as muscle mass and strength, fat distribution, bone mass and sex drive. Testosterone hormone replacement therapy has been used for decades to treat men with low testosterone levels (male hypogonadism). Testosterone replacement therapies are available in the form of an injection into the muscle, implants under the skin, oral capsules taken by mouth, topical gels applied to the skin, and skin patches. This study will use Fortesta®, a topical testosterone gel (T-gel) absorbed into the skin. Fortesta® is currently on the market as an FDA-approved treatment of male hypogonadism (low testosterone levels). Men with non-cancer related pain who take opioid-based medications for pain and have low testosterone levels may join this study. (A low testosterone level is defined as early morning (before noon) blood testosterone level of 300 ng/dl or less, or a free testosterone of 50 ng/dl or less)).

Principal SponsorJohns Hopkins University
Last updated: March 31, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesGonadal DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHypogonadismPain

Criteria

11 inclusion criteria required to participate
18 Years of Age and Older

Absence of hospitalization in past 2 months

Consumption of at least 10 mg of hydrocodone (or analgesic equivalent of another opioid) for at least 4 weeks

Men

Show More Criteria

18 exclusion criteria prevent from participating
Active psychiatric illness

Acute illness in past 2 months

Alcoholism ( > 10 drinks/week)

Any addictive and/or illicit drug use

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Testosterone Gel

Group II

Placebo
Placebo Gel

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Johns Hopkins Medical Institutions

Baltimore, United StatesOpen Johns Hopkins Medical Institutions in Google Maps
SuspendedOne Study Center