Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)
Purpose
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.
Conditions
- Pain
- Opioid Use
- Androgen Deficiency
- Back Pain
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Testosterone |
Weekly intramuscular administration at a dose of 3 mg |
|
|
Placebo Comparator Placebo |
Weekly intramuscular administration of placebo |
|
Recruiting Locations
Brigham and Women's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
More Details
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital
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.