Exploring the Role of Testosterone as a Novel Anti-Nociceptive Agent in Women With Chronic Pain and Opioid Use
Overview
- Phase
- Phase 2
- Intervention
- Testosterone Cypionate
- Conditions
- Not specified
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire
- Status
- Completed
- Last Updated
- 17 days ago
Overview
Brief Summary
The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, physical function and quality of life when compared with placebo in women with chronic back pain treated with opioids who have low testosterone.
Detailed Description
This single-center, randomized, double-blind, placebo-controlled, parallel-group trial will evaluate pain and quality of life outcomes associated with 3 months of treatment with testosterone or placebo in women aged 60 years or older with chronic non-cancer back pain who are taking opioid analgesics for at least 6 months and have low testosterone.
Investigators
Shehzad Basaria, M.D.
Professor of Medicine
Brigham and Women's Hospital
Eligibility 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/m
- •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.
Arms & Interventions
Testosterone
Weekly intramuscular administration at a dose of 3 mg
Intervention: Testosterone Cypionate
Placebo
Weekly intramuscular administration of placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire
Time Frame: 3 months
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.
Secondary Outcomes
- Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)(3 months)
- Mood and well-being, assessed using the by Positive and Negative Affect Scale (PANAS) affectivity balance scale(3 months)
- Weighted Pinprick Stimulator-induced Mechanical Pain(3 months)
- Algometer-induced Pressure Pain(3 months)
- Ice Water-induced Cold Pain and Its After-sensation(3 months)
- Sexual Function assessed by the Female Sexual Distress Scale (FSDS)(3 months)
- Physical function, assessed using the 6-minute walk test (6-MWT)(3 months)