Opioid Antagonism in Hypogonadotropic Hypogonadism
Who is this study for? Patients with idiopathic hypogonadotropic hypogonadism
What treatments are being studied? Kisspeptin+GnRH+Naloxone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with hypogonadotropic hypogonadism (HH).
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male
• Age 18-75 years
• Confirmed diagnosis of hypogonadotropic hypogonadism (low testosterone)
• Genetic sequencing data available
• All medical conditions stable
• Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg)
• Negative urine drug screening panel
• Hemoglobin
• Men on adequate testosterone replacement therapy: normal male reference range
• Men off testosterone replacement therapy: no lower than 0.5 gm/dL below the lower limit of the reference range for normal women
Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Study Coordinator
MGHReproEndoResearch@mgb.org
617-643-2308
Time Frame
Start Date: 2025-06-18
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 23
Treatments
Experimental: naloxone
one period of frequent blood sampling with IV administration of naloxone (one bolus)
Related Therapeutic Areas
Sponsors
Leads: Stephanie B. Seminara, MD