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Testosterone Therapy for Low Testosterone (PATH Trial)
PATH Trial Summary
This trial is testing whether testosterone replacement can help improve pain perception, pain tolerance, sexual function, fatigue, and quality of life in men with chronic back pain being treated with opioids who have low testosterone due to their opioid use.
PATH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPATH Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PATH Trial Design
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- I have been using opioid painkillers for at least 6 months.I have long-term back pain not caused by cancer.I have been using opioid painkillers for at least 6 months.I have not used testosterone in the last 6 months.Your blood has more red blood cells than it should.Your prostate-specific antigen (PSA) level is higher than 4 ng/mL if you are Caucasian, or higher than 3 ng/mL if you are African-American.Your blood test shows that your creatinine level is higher than 2.5 mg/dL.I haven't had a heart attack, stroke, or heart surgery in the last 3 months.I have a diagnosed condition that affects my body's ability to produce sex hormones.I have been diagnosed with bipolar disorder or schizophrenia.My testosterone levels are low according to recent tests.You have metal implants in your body that prevent you from having an MRI. If you can't have an MRI or don't want to, the researchers might still let you join the study after thinking about your situation.I am a man aged 18 or older.I have a history of prostate or breast cancer.I have a lump or hard area in my prostate found during a physical exam.I have heart failure that is not well-managed.I am a man aged 18 or older.I have long-term back pain not caused by cancer.Your ALT level is more than three times higher than the normal range.
- Group 1: Testosterone
- Group 2: Placebo
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any available openings for individuals to partake in this experiment?
"Clinicaltrials.gov records indicate that this clinical trial is currently recruiting patients, with the initial posting occurring on January 10th 2022 and a recent update being made on September 16th 2022."
What prior experiments have been done on Testosterone cypionate's effects?
"Currently, there are 29 ongoing clinical trials for Testosterone cypionate and 5 of these trials have been moved to Phase 3. While some of the studies may be located in Houston, Texas, a total of 124 medical sites offer this research opportunity globally."
What potential risks are associated with Testosterone cypionate usage?
"Testosterone cypionate's safety has been partially established, thus receiving a rating of 2 on the scale. However, efficacy remains unconfirmed given this is only a Phase 2 study."
What are the expected outcomes of this medical experiment?
"This 6-month clinical trial has a primary focus of assessing changes in scores for the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire. Furthermore, secondary outcomes include Quantitative sensory testing to measure deep pressure pain response with cuff pressure algometry, quantifying responses to pressure stimulation through digital pressure algometer readings, and gauging reactions to mechanical pain by repetitive stimuli ("windup") tests with punctate probes."
How many participants is this research endeavor recruiting?
"Affirmative. Per the data available on clinicaltrials.gov, this investigation is actively soliciting participants since its inception in January 10th 2022 and most recent refreshment on September 16th of the same year. A total of 150 individuals are required to be recruited from a single research site."
To what medical conditions is testosterone cypionate typically applied?
"Testosterone cypionate is widely prescribed to treat hypogonadotropic hypogonadism, however it can also be taken as a therapy for post-menopausal women and those that have undergone orchidectomy or orchitis."
Who else is applying?
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