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

Launched by BRIGHAM AND WOMEN'S HOSPITAL · May 17, 2021

Keywords

ClinConnect Summary

The TRAPP Trial is a study designed to find out if testosterone replacement therapy can help postmenopausal women with chronic back pain who are currently taking opioid medications. Specifically, the trial will compare the effects of testosterone to a placebo (a treatment that looks like the real thing but has no active ingredients) on pain levels, sexual function, physical ability, and overall quality of life. This research is important because many women experience ongoing pain and may not be aware that low testosterone could be contributing to their discomfort.

To participate in this study, women must be 60 years or older, have had chronic non-cancer back pain for at least six months, and have low testosterone levels. Participants will also need to be able to give informed consent and meet other health criteria, such as having a normal mammogram within the last year. If eligible, participants can expect to receive either testosterone or a placebo for the duration of the trial and will be monitored for improvements in their pain and quality of life. This study is currently recruiting participants, and it's a valuable opportunity for women looking for new ways to manage their pain.

Gender

FEMALE

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/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.