Testosterone cypionate for Pain

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pain+4 More
Testosterone cypionate - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing whether testosterone replacement can help improve pain perception, pain tolerance, sexual function, fatigue, and quality of life in men with chronic back pain being treated with opioids who have low testosterone due to their opioid use.

Eligible Conditions
  • Pain
  • Hypogonadism
  • Opioids Use

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: Baseline, 3 months, and 6 months

6 months
Catastrophizing assessed with the Pain Catastrophizing Scale (PCS) questionnaire
Depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9)
Energy, assessed with the Hypogonadism Energy Diary (HED)
Fatigue assessed with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire
Mood and well-being, assessed using the by Positive and Negative Affect Scale (PANAS) affectivity balance scale
Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire
Quality of life assessed using the 36-Item Short-Form Survey (SF-36)
Sexual function, assessed with the Sexual Arousal, Interest, and Drive (SAID) questionnaire
Baseline and 6 months
Changes in Patient's Global Impression of Change (PGIC) scores
Changes in default mode network connectivity
Month 6
Changes in catastrophizing assessed with the Pain Catastrophizing Scale (PCS) questionnaire
Changes in depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9)
Changes in energy, assessed with the Hypogonadism Energy Diary (HED)
Changes in fatigue assessed with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire
Changes in mood and well-being, assessed using the by Positive and Negative Affect Scale (PANAS) affectivity balance scale
Changes in quality of life assessed using the 36-Item Short-Form Survey (SF-36)
Changes in response to quantitative sensory testing of pain under a mechanical stimulus
Changes in response to quantitative sensory testing of pain under cold stimulus
Changes in response to quantitative sensory testing of pain under deep pressure stimulus
Changes in response to quantitative sensory testing of pain under heat stimulus
Changes in response to quantitative sensory testing of pain under pressure stimulus
Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire
Changes in sexual function, assessed with the Sexual Arousal, Interest, and Drive (SAID) questionnaire
Quantitative sensory testing of pain under a mechanical stimulus
Quantitative sensory testing of pain under cold stimulus
Quantitative sensory testing of pain under deep pressure stimulus
Quantitative sensory testing of pain under heat stimulus
Quantitative sensory testing of pain under pressure stimulus

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Cohort A:Post-enzalutamide
57%fatigue
40%Musculoskeletal pain
37%Increased Hemoglobin
23%Hypertension
23%nausea
17%rash
17%Anemia
17%Breast Tenderness
17%hot flashes
17%cough
13%edema
13%gynecomastia
13%pruritis
13%dizziness
13%weight loss
10%headache
10%Creatinine Increased
10%High cholesterol
10%abdominal pain
10%anorexia
10%sinusitis
10%fall
10%constipation
10%eye discorder
7%Syncope
7%chest pain
7%cold symptoms
3%Elevated hematocrit
3%insomnia
3%gallstone
3%Taster change
3%Elevated potassium
3%fever
3%Acute Renal Insufficiency
3%myocardial infarction
3%diarrhea
3%Pancreatitis, elevated lipase, amylase
3%anxiety
3%Elevated liver enzymes
3%Shortness of breath
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02090114) in the Cohort A:Post-enzalutamide ARM group. Side effects include: fatigue with 57%, Musculoskeletal pain with 40%, Increased Hemoglobin with 37%, Hypertension with 23%, nausea with 23%.

Trial Design

2 Treatment Groups

Testosterone
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

150 Total Participants · 2 Treatment Groups

Primary Treatment: Testosterone cypionate · Has Placebo Group · Phase 2

TestosteroneExperimental Group · 2 Interventions: Testosterone cypionate, Testosterone Undecanoate 250 MG/ML · Intervention Types: Drug, Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months, and 6 months

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,470 Previous Clinical Trials
9,707,493 Total Patients Enrolled
14 Trials studying Pain
1,073 Patients Enrolled for Pain
Robert R Edwards, PhDPrincipal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
398 Total Patients Enrolled
Shehzad Basaria, MDPrincipal InvestigatorBrigham and Women's Hospital
3 Previous Clinical Trials
333 Total Patients Enrolled
1 Trials studying Pain
84 Patients Enrolled for Pain

Eligibility Criteria

Age 18+ · Male Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 7th, 2021

Last Reviewed: November 6th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Virginia50.0%
Ohio50.0%
How old are they?
65+50.0%
18 - 6550.0%
What site did they apply to?
Brigham and Women's Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria66.7%
Did not meet criteria33.3%
References