Status:
ACTIVE_NOT_RECRUITING
Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Pain
Opioid Use
Eligibility:
FEMALE
60+ years
Phase:
PHASE2
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 com...
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 placeb...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04895306
Start Date
November 15 2022
End Date
June 30 2026
Last Update
December 24 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115