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SC
Overseen ByStudy Coordinator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Stephanie B. Seminara, MD
Must be taking: Reproductive condition treatments
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks new treatments for individuals with hypogonadotropic hypogonadism (HH), a condition that causes low testosterone levels. Researchers are testing a treatment called kisspeptin to determine if it can boost hormone levels. Participants will receive kisspeptin and another treatment, GnRH (a hormone therapy), through an IV. This trial may suit those with long-term low testosterone who have not recently used medications affecting reproductive hormones. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you stop taking any prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug, whichever is shorter, unless they are used to treat your reproductive condition.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that kisspeptin, a natural hormone, is generally safe for people. Studies have found that kisspeptin can raise hormone levels such as LH (luteinizing hormone) and sometimes testosterone, suggesting it functions safely in the body and may aid reproductive health.
For GnRH (gonadotropin-releasing hormone), research indicates it is safe when used in treatments. It is often employed to test and treat hormone-related issues. Some studies suggest it can lead to changes in body weight and composition, but these effects are typically manageable.
Overall, both kisspeptin and GnRH have been studied for their safety and are considered well-tolerated in people. However, individual responses to treatments can vary. It is important to consult a doctor for personalized advice.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about kisspeptin 112-121 for low testosterone because it introduces a novel approach to hormone regulation. Unlike traditional testosterone replacement therapies, which directly supplement testosterone, kisspeptin works by stimulating the body's natural hormone pathways. This treatment targets the release of Gonadotropin-releasing hormone (GnRH), which can help boost testosterone levels more naturally and potentially reduce the risk of side effects associated with direct hormone replacement. Additionally, its intravenous administration over a short period offers a unique dosing strategy that could lead to quick and effective results.
What evidence suggests that this trial's treatments could be effective for hypogonadotropic hypogonadism?
Research has shown that kisspeptin, a natural hormone, can increase the release of luteinizing hormone (LH) in men, which then boosts testosterone levels. One study found that a form of kisspeptin, called kisspeptin-10, increased both the frequency and amount of LH release, leading to higher testosterone levels. In this trial, participants will receive kisspeptin 112-121 as part of the treatment. Additionally, the trial includes the administration of GnRH, which other studies have shown to increase testosterone levels in most patients over time, with about 93% of men reaching normal levels. These treatments hold promise for improving testosterone levels in conditions like hypogonadotropic hypogonadism (HH).678910
Who Is on the Research Team?
Stephanie B. Seminara, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?Adults diagnosed with hypogonadotropic hypogonadism (HH) can join this trial if their condition is stable and they're not on meds affecting reproductive hormones, except for HH treatment. Women must not be pregnant or breastfeeding, and all participants need normal blood tests, hormone levels within certain ranges, no drug allergies needing emergency care, and no excessive alcohol use.
Inclusion Criteria
Women need to have a negative pregnancy test before starting the study.
I have been diagnosed with hypogonadotropic hypogonadism and have low testosterone or estradiol levels.
I have been diagnosed with HH and never had a severe reaction to medication.
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Exclusion Criteria
No illicit drug use
You drink less than 10 alcoholic drinks per week.
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person)
Treatment
Participants receive kisspeptin intravenous boluses and undergo blood sampling
52 hours
Inpatient stay with continuous monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
1-2 weeks
1 visit (in-person)
What Are the Treatments Tested in This Trial?
Interventions
GnRH kisspeptin 112-121
Trial Overview
The study is testing the effectiveness of kisspeptin 112-121 in treating low testosterone due to HH. It aims to develop new treatments by administering kisspeptin externally. Participants will receive either GnRH or kisspeptin as part of the trial interventions.
How Is the Trial Designed?
Treatment groups
Experimental Treatment
Group I: Experimental: kisspeptin, GnRHExperimental Treatment2 Interventions
• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stephanie B. Seminara, MD
Lead Sponsor
Trials
10
Recruited
840+
Published Research Related to This Trial
Citations