Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)
CompletedPhase 2NCT04895306
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Exploring the Role of Testosterone as a Novel Anti-Nociceptive Agent in Women With Chronic Pain and Opioid Use
- Conditions
- Pain
- Opioid Use
- Androgen Deficiency
- Back Pain
- Interventions
- Drug: Testosterone Cypionate
- Drug: Placebo
- Sponsor
- Brigham and Women's Hospital
- Collaborators
- National Institutes of Health (NIH)
- Start date
- 2022-11-15
- Primary completion
- 2026-03-27
- Sex
- Female
- Age range
- from 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04895306