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

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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.