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Opioid Antagonist Therapy for Low Testosterone
Study Summary
This trial will test if opioid antagonists can help with idiopathic hypogonadotropic hypogonadism by looking at the subject's hypothalamic-pituitary-gonadal axis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I can stop my hormone therapy for a certain period if needed.Women must have a negative pregnancy test before joining the study, and another test may be done before taking the medication.I haven't taken drugs affecting my hormones except for treating my reproductive condition.Your blood tests for BUN, creatinine, AST, and ALT should not show high levels.You do not drink more than 10 alcoholic drinks per week.My other health conditions are stable and under control.Your MRI does not show any unusual findings in your pituitary or hypothalamus.Your thyroid stimulating hormone (TSH) and prolactin levels are within the normal range.Your blood pressure is within the normal range (systolic BP < 140 mm Hg, diastolic < 90 mm Hg).Your white blood cell, platelet counts, and TSH levels should be within a certain range, not too low or too high.I am not pregnant or breastfeeding.Your urine drug test must show that you are not using any drugs.My hemoglobin levels are within the normal range for my gender.You do not use opioid drugs.Your gonadotropin levels are lower than normal.I have been diagnosed with hypogonadotropic hypogonadism and have low testosterone or estradiol levels.
- Group 1: kisspeptin, GnRH, naloxone
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is there any risk associated with the combination of kisspeptin, GnRH, and naloxone?
"Our team has determined that kisspeptin, GnRH and naloxone are moderately safe based on our Phase 2 trial data. While efficacy is yet unproven, safety protocols have been tested multiple times with success."
Are there still opportunities for participants to join this clinical experiment?
"Affirmative. According to the records hosted on clinicaltrials.gov, this research is currently recruiting subjects; it was initiated on December 31st 2022 and modified lastly on June 29th of that same year. This study requires 23 volunteers who can be sourced from a single medical centre."
Could I be eligible to partake in this trial?
"The clinical trial is offering enrollment to 23 individuals affected by hypogonadism, aged 18-75. Applicants must meet certain criteria such as normal or low levels of gonadotropins, no abnormalities on MRI scans of the pituitary and hypothalamus glands, TSH and prolactin within a specific range, documented cases of HH with reduced testosterone/estradiol production, stable health conditions not requiring medication for at least 2 months (or 5 half lives), no medical history necessitating emergency care due to drug reaction nor opiate usage nor excessive alcohol consumption (<10 drinks weekly)."
Does this trial admit participants older than twenty years of age?
"This clinical trial is designed for participants aged between 18 and 75, while there exist 12 studies catering to individuals below the legal age of consent and 70 others tailored towards elderly patients."
What is the total cohort size for this research endeavor?
"Affirmative. The clinical trial database verifies that this study, which was initially listed on December 31st 2022, is actively recruiting patients. A total of 23 individuals must be recruited from 1 medical site."
What prior research has been conducted on the interplay between kisspeptin, GnRH and naloxone?
"At present, 19 trials for kisspeptin, GnRH and naloxone are in Phase 3 with a further 80 active studies. White River Junction, Vermont is one of 1,436 sites that are hosting investigations into this subject matter."
In what medical contexts are kisspeptin, GnRH and naloxone typically prescribed?
"The medications kisspeptin, GnRH and naloxone are proven effective for treating opioids. Beyond this use-case, they have also been applied to address pain, pruritus, and septic shock."
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