A Phase 2 interventional study of Testosterone Undecanoate 250 MG/ML and Placebo in Opioid Use, Pain and Hypogonadism, Male, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment
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).
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 150 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intramuscular injections of testosterone undecanoate 750 mg.
Drug: Testosterone Undecanoate 250 MG/ML
Intramuscular injections of placebo.
Drug: Placebo
Drug page: Testosterone undecanoate
Intramuscular administration at a dose of 750 mg at baseline, weeks 4, and week 14.
Also known as: Testosterone
Intramuscular administration of placebo at baseline, weeks 4, and week 14.
Also known as: Control
Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire
The Pain Interference Subscale of the BPI is specifically relevant to patients with chronic back pain who are using opioids and correlates strongly with the patient's quality of life.
Time frame: Baseline, 3 months, and 6 months
Changes in response to quantitative sensory testing of pain under pressure stimulus
Responses to pressure stimulation (pressure pain threshold) will be evaluated using a digital pressure algometer.
Time frame: Baseline, 3 months, and 6 months
Changes in response to quantitative sensory testing of pain under deep pressure stimulus
Response to deep pressure pain will be ascertained using cuff pressure algometry.
Time frame: Baseline, 3 months, and 6 months
Changes in response to quantitative sensory testing of pain under a mechanical stimulus
Responses to mechanical pain will be assessed using repetitive stimuli (temporal summation or "windup") with a set of punctate mechanical probes.
Time frame: Baseline, 3 months, and 6 months
Changes in response to quantitative sensory testing of pain under heat stimulus
Responses to heat pain will be assessed using a contact thermode that will deliver thermal stimulation to the skin.
Time frame: Baseline, 3 months, and 6 months
Changes in response to quantitative sensory testing of pain under cold stimulus
Responses to cold pain will be assessed using a cold pressor task, which involves immersion of the dominant hand in a circulating water bath at a temperature of 4°C.
Time frame: Baseline, 3 months, and 6 months
Changes in default mode network connectivity
Patients with chronic pain show increased default mode network (DMN) connectivity to the anterior/mid-insula, a brain region that integrates multiple dimensions of pain, while reduced DMN connectivity to the insula has been significantly associated with pain reduction. In this trial, we plan to determine the influence of testosterone replacement on DMN connectivity by performing functional magnetic resonance imaging (MRI) before and after testosterone/placebo administration and correlate changes in pain with changes in DMN connectivity.
Time frame: Baseline and 6 months
Changes in quality of life assessed using the 36-Item Short-Form Survey (SF-36)
The SF-36 measures eight QOL domains: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. The questionnaire also includes a single item that provides an indication of perceived change in health.
Time frame: Baseline, 3 months, and 6 months
Changes in depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a validated health questionnaire that will be administered in this trial to evaluate depression among the participants.
Time frame: Baseline, 3 months, and 6 months
Changes in mood and well-being, assessed using the by Positive and Negative Affect Scale (PANAS) affectivity balance scale
The PANAS affectivity balance scale includes 10 questions evaluating positive and negative affect.
Time frame: Baseline, 3 months, and 6 months
Changes in energy, assessed with the Hypogonadism Energy Diary (HED)
The HED questionnaire is a self-administered instrument that evaluates energy levels in men with hypogonadism.
Time frame: Baseline, 3 months, and 6 months
Changes in sexual function, assessed with the Sexual Arousal, Interest, and Drive (SAID) questionnaire
The SAID questionnaire is a five-item self-administered instrument that evaluates the level of thinking about sex, arousal, and rating the level of interest in sex and sex drive in men with hypogonadism.
Time frame: Baseline, 3 months, and 6 months
Changes in fatigue assessed with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire
The FACIT-F questionnaire is a self-reported instrument that evaluates fatigue and its impact on daily activities and function.
Time frame: Baseline, 3 months, and 6 months
Changes in catastrophizing assessed with the Pain Catastrophizing Scale (PCS) questionnaire
The PCS is a measure of cognitive and affective responses to pain that consists of 13 items assessing the pain catastrophizing domains of rumination, magnification, and helplessness.
Time frame: Baseline, 3 months, and 6 months
Changes in Patient's Global Impression of Change (PGIC) scores
The PGIC is a questionnaire that asks how subjects feel their health status has changed at the end of the study compared with baseline.
Time frame: Baseline and 6 months
Plan to share: No
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Studies of the drug tested here: Testosterone undecanoate
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