Testosterone treatment for pain relief in older women
Exploring the Role of Testosterone as a Novel Anti-Nociceptive Agent in Women With Chronic Pain and Opioid Use
This study is testing if testosterone treatment can help older women with chronic back pain feel less pain and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 60 Years and up |
| Sex | Female |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04895306 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effects of testosterone replacement therapy on pain perception, tolerance, sexual function, physical function, and quality of life in postmenopausal women aged 60 and older with chronic non-cancer back pain who have low testosterone levels and are currently using opioid analgesics. It is a single-center, randomized, double-blind, placebo-controlled study that compares the outcomes of testosterone treatment to a placebo over a period of three months. The goal is to determine if testosterone can provide significant improvements in these areas compared to no treatment.
Who should consider this trial
Good fit: Ideal candidates are women aged 60 years and older with chronic non-cancer back pain, low testosterone levels, and who have been using opioid analgesics for at least six months.
Not a fit: Patients with a history of breast or endometrial cancer, uncontrolled heart conditions, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new option for pain management and improved quality of life for postmenopausal women suffering from chronic back pain.
How similar studies have performed: While testosterone therapy has been explored in various contexts, this specific approach targeting pain relief in postmenopausal women with opioid use is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women, age 60 years and older. * Chronic non-cancer back pain. * Use of opioid analgesics for at least 6 months. * Serum total testosterone \<8.7 ng/dL and/or free testosterone \<0.47 pg/mL. * Normal mammogram within the last 12 months * Endometrial thickness of \<4 mm in women with an intact uterus assessed by endometrial ultrasound. * Ability and willingness to provide informed consent. Exclusion Criteria: * History of breast or endometrial cancer * Estrogen therapy in the past 3 months * Baseline hematocrit \>48%. * Serum creatinine \>2.5 mg/dL. * HbA1c \>9.0%. Subjects on insulin therapy will be excluded. * BMI \>40 kg/m2. * Uncontrolled congestive heart failure. * Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within the past 3 months. * History of genetic thromboembolic disorder. * Diagnosis of bipolar disorder or schizophrenia. * Use of testosterone, spironolactone, finasteride or systemic ketoconazole in the past 3 months.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Shehzad Basaria, M.D. — Brigham and Women's Hospital
- Study coordinator: Julia Crosby
- Email: jpcrosby@bwh.harvard.edu
- Phone: 617-525-6726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.