Testosterone cypionate for Pain
Phase-Based Progress Estimates
Effectiveness
Safety
Pain+4 More
Testosterone cypionate - DrugEligibility
18+
Male
What conditions do you have?
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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
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
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
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: DrugTreatment
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 - 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?
| Virginia | 50.0% |
| Ohio | 50.0% |
How old are they?
| 65+ | 50.0% |
| 18 - 65 | 50.0% |
What site did they apply to?
| Brigham and Women's Hospital | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 66.7% |
| Did not meet criteria | 33.3% |
References
- Chou, Roger, Judith A. Turner, Emily B. Devine, Ryan N. Hansen, Sean D. Sullivan, Ian Blazina, Tracy Dana, Christina Bougatsos, and Richard A. Deyo. 2015. “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”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/m14-2559.
- Rajagopal, Arun, Rena Vassilopoulou-Sellin, J. Lynn Palmer, Guddi Kaur, and Eduardo Bruera. 2004. “Symptomatic Hypogonadism in Male Survivors of Cancer with Chronic Exposure to Opioids”. Cancer. Wiley. doi:10.1002/cncr.20028.
- Basaria, Shehzad, Thomas G. Travison, Daniel Alford, Philip E. Knapp, Kjersten Teeter, Christine Cahalan, Richard Eder, et al.. 2015. “Effects of Testosterone Replacement in Men with Opioid-induced Androgen Deficiency”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.j.pain.0000460308.86819.aa.
- Edwards, R.R., A.J. Dolman, E. Michna, J.N. Katz, S.S. Nedeljkovic, D. Janfaza, Z. Isaac, M.O. Martel, R.N. Jamison, and A.D. Wasan. 2016. “Changes in Pain Sensitivity and Pain Modulation During Oral Opioid Treatment: The Impact of Negative Affect”. Pain Medicine. Oxford University Press (OUP). doi:10.1093/pm/pnw010.
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- Basaria, Shehzad. 2014. “Male Hypogonadism”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(13)61126-5.
- Fillingim, Roger B., and Robert R. Edwards. 2001. “The Association of Hormone Replacement Therapy with Experimental Pain Responses in Postmenopausal Women”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0304-3959(01)00256-1.
- Meints, Samantha M., Ishtiaq Mawla, Vitaly Napadow, Jian Kong, Jessica Gerber, Suk-Tak Chan, Ajay D. Wasan, et al.. 2018. “The Relationship Between Catastrophizing and Altered Pain Sensitivity in Patients with Chronic Low-back Pain”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/j.pain.0000000000001461.
- Katz, Nathaniel, and Norman A. Mazer. 2009. “The Impact of Opioids on the Endocrine System”. The Clinical Journal of Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ajp.0b013e3181850df6.
- Aloisi, Anna, Ilaria Ceccarelli, Maria Carlucci, Annalisa Suman, Gianfranco Sindaco, Sergio Mameli, Valentina Paci, et al.. 2011. “Hormone Replacement Therapy in Morphine-induced Hypogonadic Male Chronic Pain Patients”. Reproductive Biology and Endocrinology. Springer Science and Business Media LLC. doi:10.1186/1477-7827-9-26.
- Edwards RR, Dolman AJ, Michna E, Katz JN, Nedeljkovic SS, Janfaza D, Isaac Z, Martel MO, Jamison RN, Wasan AD. Changes in Pain Sensitivity and Pain Modulation During Oral Opioid Treatment: The Impact of Negative Affect. Pain Med. 2016 Oct;17(10):1882-1891. doi: 10.1093/pm/pnw010. Epub 2016 Mar 1.
- Basaria S. Male hypogonadism. Lancet. 2014 Apr 5;383(9924):1250-63. doi: 10.1016/S0140-6736(13)61126-5. Epub 2013 Oct 10.
- Daniell HW, Lentz R, Mazer NA. Open-label pilot study of testosterone patch therapy in men with opioid-induced androgen deficiency. J Pain. 2006 Mar;7(3):200-10. doi: 10.1016/j.jpain.2005.10.009.
- 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.
- Katz N, Mazer NA. The impact of opioids on the endocrine system. Clin J Pain. 2009 Feb;25(2):170-5. doi: 10.1097/AJP.0b013e3181850df6.
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