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Testosterone Gel for Cancer-Related Fatigue (TEMEC Trial)
TEMEC Trial Summary
This trial is testing whether testosterone replacement can help with cancer-related fatigue in older men who have low testosterone levels.
TEMEC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTEMEC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TEMEC Trial Design
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Who is running the clinical trial?
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- I have a genetic condition that causes blood clots.I am not taking any glucocorticoids, except as part of chemotherapy.I often feel very tired, more than usual.I am a man with a history of hormone-dependent cancer.My PSA level is above 4, or I have a nodule found during a rectal exam.I haven't taken appetite stimulants like megestrol in the last month.I haven't had a heart attack, stroke, or any related surgery in the last 6 months.I am a man with lung or colorectal cancer, treated with chemo or radiation, and have been NED for less than 24 months.My testosterone levels are low, below the normal range.I have had a stroke that left me with thinking or physical difficulties.I am a man with cancer that has spread to my brain.You have been diagnosed with bipolar disorder or schizophrenia.You are expected to live for at least 6 more months.I am 55 years old or older.I have heart failure that is not well-managed.I have severe sleep apnea that hasn't been treated.I am 55 years old or older.I have not used any anabolic agents like testosterone in the last 6 months.You are expected to live for at least 6 more months.
- Group 1: testosterone 1.62% gel
- Group 2: placebo gel
- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
Frequently Asked Questions
Are we still able to enroll patients in this clinical trial?
"According to the website clinicaltrials.gov, this particular trial is still looking for participants and is currently in the recruitment stage. This trial was first posted on 1/12/2021 and was last edited on 3/9/2022."
Has research been published on 1.62% testosterone gel in the past?
"At this time, there are a total of 32 active studies on testosterone 1.62% gel with 5 being in Phase 3. Most investigations for testosterone 1.62% gel take place in Houston, Texas; however, there are 158 locations worldwide conducting clinical trials for this medication."
Could you please list the potential side effects of using testosterone 1.62% gel?
"Although there is some evidence indicating that testosterone 1.62% gel is safe, it only received a score of 2 because this is a Phase 2 trial with no data supporting efficacy."
What is the general purpose of testosterone 1.62% gel?
"Patients suffering from hypogonadotropic hypogonadism, post-menopausal women 1 to 5 years after menopause, and those that have had an orchidectomy can all be treated with testosterone 1.62% gel."
How many participants are being welcomed into this research?
"That is correct. According to the listings on clinicaltrials.gov, this study is still looking for participants. The posting date was 1/12/2021 with a most recent update on 3/9/2022. They are aiming to enroll 230 total patients from 3 different locations."
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