NCT04975334

Opioid Antagonism in Hypogonadotropic Hypogonadism

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Stephanie B. Seminara, MD · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Assignment: Each study subject will serve as their own control. Delivery of Interventions: * Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. * During the study, the subjects will undergo the following: * Undergo q10 min blood sampling for 3 hours * Receive a naloxone bolus at the midpoint of q10 min sampling

Conditions

• Hypogonadotropic Hypogonadism
• Low Testosterone

Interventions

Type	Name	Description
DRUG	Naloxone	One bolus of naloxone

Timeline

• Start date: 2025-06-18
• Primary completion: 2025-09-26
• Completion: 2025-09-26
• First posted: 2021-07-23
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study