Testosterone Therapy for Pain in Postmenopausal Women
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot have used testosterone, spironolactone, finasteride, or systemic ketoconazole in the past 3 months.
What evidence supports the effectiveness of testosterone therapy for pain in postmenopausal women?
Is testosterone therapy safe for postmenopausal women?
Studies suggest that testosterone therapy in women, including postmenopausal women, generally has a good safety profile. It has shown favorable effects on cardiovascular health and cognitive performance, with no adverse cardiovascular effects observed in studies of transdermal testosterone therapy. However, more research is needed to fully understand its long-term safety and effects on cancer risk.46789
How does the drug Testosterone Cypionate differ from other treatments for pain in postmenopausal women?
Testosterone Cypionate is unique because it addresses symptoms potentially linked to low testosterone levels, such as fatigue and low libido, which are not typically targeted by standard pain treatments for postmenopausal women. This drug may improve overall well-being by supplementing testosterone, which is often reduced after menopause.12101112
Research Team
Shehzad Basaria, M.D.
Principal Investigator
Brigham and Women's Hospital
Eligibility Criteria
This trial is for postmenopausal women over 60 with chronic back pain who have been on opioids for at least 6 months and show low testosterone levels. They must have a normal mammogram, appropriate endometrial thickness, and be able to consent. Women with a history of certain cancers, severe obesity, recent heart issues or strokes, specific blood conditions or kidney dysfunction are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly intramuscular administration of testosterone or placebo for 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- Testosterone Cypionate
Testosterone Cypionate is already approved in United States for the following indications:
- Primary hypogonadism
- Hypogonadotropic hypogonadism
- Delayed puberty
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
National Institutes of Health (NIH)
Collaborator