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Recruiting NCT04798469

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Phase II Interventional Opioid Use Pain Hypogonadism, Male

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Testosterone Undecanoate 250 MG/ML, Placebo.
Who it may be relevant to
Registry conditions: Opioid Use, Pain, Hypogonadism, Male. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism

Overview

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).

Detailed description

This single-center, randomized, double-blind, placebo-controlled, parallel-group trial will evaluate pain and quality of life outcomes associated with 6 months of treatment with testosterone or placebo in men aged 18 years or older with chronic non-cancer spinal pain who are taking opioid analgesics for at least 6 months and have opioid-induced hypogonadism.

Interventions

  • Drug Testosterone Undecanoate 250 MG/ML
    Intramuscular administration at a dose of 750 mg at baseline, weeks 4, and week 14.
  • Drug Placebo
    Intramuscular administration of placebo at baseline, weeks 4, and week 14.

Primary outcome measures

  • Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire [Time frame: Baseline, 3 months, and 6 months]
Secondary outcome measures (6)
  • Changes in response to quantitative sensory testing of pain under pressure stimulus [Time frame: Baseline, 3 months, and 6 months]
  • Changes in response to quantitative sensory testing of pain under deep pressure stimulus [Time frame: Baseline, 3 months, and 6 months]
  • Changes in response to quantitative sensory testing of pain under a mechanical stimulus [Time frame: Baseline, 3 months, and 6 months]
  • Changes in response to quantitative sensory testing of pain under heat stimulus [Time frame: Baseline, 3 months, and 6 months]
  • Changes in response to quantitative sensory testing of pain under cold stimulus [Time frame: Baseline, 3 months, and 6 months]
  • Changes in default mode network connectivity [Time frame: Baseline and 6 months]

Eligibility criteria

Inclusion criteria

  • Men, age 18 years and older.
  • Chronic non-cancer spinal pain.
  • Use of opioid analgesics for at least 6 months.
  • Serum total testosterone (measured by mass spectrometry) <348 ng/dL and/or free testosterone <70 pg/mL.
  • Ability and willingness to provide informed consent.

Exclusion criteria

  • History of prostate cancer or breast cancer.
  • Known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or testicular disease).
  • Use of testosterone within the past 6 months.
  • Baseline hematocrit >48%.
  • Prostate-specific antigen (PSA) level >4 ng/mL in Caucasians or >3 ng/mL in African-Americans.
  • Presence of prostate nodule or induration on digital rectal examination.
  • Uncontrolled congestive heart failure.
  • Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 3 months.
  • Serum creatinine >2.5 mg/dL.
  • Alanine aminotransferase (ALT) level 3 times above the upper limit of normal.
  • Diagnosis of bipolar disorder or schizophrenia.
  • Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the patient from undergoing functional magnetic resonance imaging (MRI). In subjects who are otherwise eligible and either do not qualify for MRI or are reluctant to undergo imaging, the investigators may consider enrolling such participants on a case-by-case basis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Brigham and Women's Hospital — Boston

Publications

  • Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559. PMID 25581257
  • Von Korff M, Kolodny A, Deyo RA, Chou R. Long-term opioid therapy reconsidered. Ann Intern Med. 2011 Sep 6;155(5):325-8. doi: 10.7326/0003-4819-155-5-201109060-00011. PMID 21893626
  • Aloisi AM, Ceccarelli I, Fiorenzani P. Gonadectomy affects hormonal and behavioral responses to repetitive nociceptive stimulation in male rats. Ann N Y Acad Sci. 2003 Dec;1007:232-7. doi: 10.1196/annals.1286.022. PMID 14993056
  • Fillingim RB, Edwards RR, Powell T. The relationship of sex and clinical pain to experimental pain responses. Pain. 1999 Dec;83(3):419-425. doi: 10.1016/S0304-3959(99)00128-1. PMID 10568849
  • Basaria S. Male hypogonadism. Lancet. 2014 Apr 5;383(9924):1250-63. doi: 10.1016/S0140-6736(13)61126-5. Epub 2013 Oct 10. PMID 24119423
  • Fillingim RB, Edwards RR. The association of hormone replacement therapy with experimental pain responses in postmenopausal women. Pain. 2001 May;92(1-2):229-34. doi: 10.1016/s0304-3959(01)00256-1. PMID 11323144
  • Daniell HW. Hypogonadism in men consuming sustained-action oral opioids. J Pain. 2002 Oct;3(5):377-84. doi: 10.1054/jpai.2002.126790. PMID 14622741
  • Rajagopal A, Vassilopoulou-Sellin R, Palmer JL, Kaur G, Bruera E. Symptomatic hypogonadism in male survivors of cancer with chronic exposure to opioids. Cancer. 2004 Feb 15;100(4):851-8. doi: 10.1002/cncr.20028. PMID 14770444

Identifiers

NCT: NCT04798469 · 2021P000331

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗