Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial) (NCT04895306) | Clinical Trial Compass
CompletedPhase 2
Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)
United States36 participantsStarted 2022-11-15
Plain-language 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.
Who can participate
Age range60 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire