Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorBrigham and Women's Hospital
About 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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%.
Trial design
Design model
Parallel
Treatments tested in this trial
Testosterone Undecanoate 250 MG/ML
DrugIntramuscular administration at a dose of 750 mg at baseline, weeks 4, and week 14.
Placebo
DrugIntramuscular administration of placebo at baseline, weeks 4, and week 14.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: TestosteroneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsOther outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov