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 range
60 Years
Sex
FEMALE
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire