Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)

Completed · Phase 2 · Has a placebo group

Conditions studied: Pain, Opioid Use, Androgen Deficiency, Back Pain

In brief

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.

Key facts

Study ID: NCT04895306
Run by: Brigham and Women's Hospital
People needed: 36
Starts: 2022-11-15
Expected to finish: 2026-03-27
Last updated by the study team: 2026-04-15

Who can join

Age: 60 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 it is running

Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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