Testosterone and Pain Sensitivity

NCT ID: NCT01689896

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-03-31

Brief Summary

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)).

Conditions

Low Testosterone; Hypogonadism; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Testosterone Gel

Testosterone Gel

Group Type: ACTIVE_COMPARATOR

Testosterone Gel

Intervention Type: DRUG

Placebo Gel

Placebo Gel

Group Type: PLACEBO_COMPARATOR

Placebo Gel

Intervention Type: DRUG

Interventions

Testosterone Gel

Intervention Type: DRUG

Placebo Gel

Intervention Type: DRUG

Other Intervention Names

Fortesta®

Eligibility Criteria

Inclusion Criteria

• Men
• 18 Years of Age and Older
• Serum total testosterone level <300 ng/dl or free testosterone < 50 pg/ml
• Consumption of at least 10 mg of hydrocodone (or analgesic equivalent of another opioid) for at least 4 weeks
• Absence of hospitalization in past 2 months
• No acute illness in past 2 months
• No prior history of any form of hypogonadism
• No current anabolic therapy (growth hormone, DHEA, etc)
• No current use or consumption in past 2 months of glucocorticoids and melatonin
• Normal digital rectal examination
• Normal PSA level

Exclusion Criteria

• Liver enzymes >3 times upper limit of normal
• Serum creatinine > 2 times upper limit of normal
• Neurological disease
• Active psychiatric illness
• Any addictive and/or illicit drug use
• Alcoholism (>10 drinks/week)
• Patients currently receiving glucocorticoids, melatonin or anabolic agents
• Hospitalization in past 2 months
• Acute illness in past 2 months
• Consumption of < 20 mg of hydrocodone (or analgesic equivalent of another opioid)
• Severe BPH
• PSA >4.0 ng/ml
• Prostate cancer
• Breast cancer
• Any cancer or cancer related pain
• History of alcohol abuse
• Known peripheral neuropathy (any etiology) or peripheral vascular disease (including Raynaud's disease), which may interfere with pain testing
• Concurrent warfarin treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Adrian S. Dobs

Professor of Medicine and Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00070640

Identifier Type: -

Identifier Source: org_study_id