Opioid Antagonist Therapy for Low Testosterone
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to examine how opioid antagonists, such as naloxone, affect hormone levels in men with low testosterone due to hypogonadotropic hypogonadism (HH). Researchers seek to understand the treatment's impact on the body's hormone-regulating system. Men diagnosed with HH, who have stable medical conditions and normal blood pressure, might be suitable candidates for this trial. Participants will receive treatments like kisspeptin (a hormone therapy) and GnRH (gonadotropin-releasing hormone) to explore potential benefits. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial requires that you stop taking any medications that can affect the reproductive system or the opioid pathway. If you're on such medications, you must be willing to go through a washout period (time without taking these medications) before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that naloxone, a drug that counteracts opioids, is generally safe for people. The FDA has already approved it to reverse opioid overdoses, indicating its safety is well understood. This study examines how naloxone affects hormone levels in people with low testosterone.
As a Phase 1 study, researchers are closely monitoring the treatment's safety. Phase 1 trials mark the first time a new treatment is tested in humans, so limited safety information exists. However, the trial team will carefully watch for any side effects to ensure participant safety.
Overall, naloxone is considered safe enough for this initial testing. Participants might experience some common side effects, but the trial team will monitor for any problems.12345Why are researchers excited about this trial's treatments?
Most treatments for low testosterone focus on directly boosting testosterone levels through hormone replacement or stimulating the body to produce more testosterone. But the therapy involving naloxone, an opioid antagonist, is different because it targets the opioid system to potentially regulate hormone levels indirectly. Researchers are excited about this approach because naloxone could offer a novel way to address low testosterone by addressing underlying opioid receptor activity, which isn’t the focus of current standard treatments. This unique mechanism may provide a new pathway for treatment, potentially benefiting patients who may not respond well to conventional methods.
What evidence suggests that this trial's treatments could be effective for low testosterone?
Research suggests that medications like naloxone, which block the effects of opioids, might help with low testosterone levels in individuals with hypogonadotropic hypogonadism (HH). Opioids can lower testosterone, leading to opioid-induced androgen deficiency. Studies have found that these blocking medications can positively affect the body's hormone system, particularly the part responsible for testosterone production. This trial will administer naloxone to participants to explore its potential to counter the hormone-suppressing effects of opioids, although direct evidence of naloxone increasing testosterone remains limited.12367
Who Is on the Research Team?
Stephanie B. Seminara, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults with low testosterone or estradiol due to hypogonadotropic hypogonadism (HH), who are not currently seeking fertility, and have stable medical conditions. Participants should not be on medications affecting reproductive functions, have no history of severe medication reactions, and must pass certain blood tests.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Period 1
Participants undergo q10 min blood sampling for up to 12 hours without medication
Period 2
Participants undergo q10 min blood sampling for up to 12 hours with naloxone bolus and infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GnRH
- Kisspeptin, GnRH
- Naloxone
Trial Overview
The study is testing the impact of opioid antagonists like naloxone on the hormonal axis in people with idiopathic HH. It aims to understand how blocking opioids affects hormones that control reproductive functions using substances such as kisspeptin and GnRH.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
one period of frequent blood sampling with IV administration of naloxone (one bolus)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stephanie B. Seminara, MD
Lead Sponsor
Published Research Related to This Trial
Citations
Low Testosterone Among Males in Opioid Agonist Therapy ...
The aim of this study was to investigate the prevalence of low testosterone levels using calculated free testosterone, assess the thresholds for low ...
Opioid Antagonism in Hypogonadotropic Hypogonadism
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with hypogonadotropic ...
Acute reductions in serum testosterone levels by narcotics ...
All narcotics depressed testosterone levels significantly and their potency relative to morphine was comparable to that observed in several other preparations.
Long-term Opioids Linked to Hypogonadism and the Role of ...
Narcotics have both central and peripheral effects causing reduced serum testosterone levels. The clinicians should look for these lesser ...
Opioid‐induced androgen deficiency in men
The prevalence of opioid-induced androgen deficiency in men varies between 20% and 80% and is influenced by the type of opioid used, duration of exposure, age ...
Opioid-induced androgen deficiency (OPIAD)
Persistently, low testosterone levels are associated with adverse musculoskeletal, metabolic, and neuropsychiatric consequences. Opioid adverse effects ...
Substance Abuse and Male Hypogonadism
This review summarizes the most important clinical and experimental evidence on the effect of substance abuse on testosterone and sperm production.
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