Opioid Antagonism in Hypogonadotropic Hypogonadism

  • STATUS
    Not Recruiting
  • End date
    Feb 28, 2025
  • participants needed
    23
  • sponsor
    Stephanie B. Seminara, MD
Updated on 3 April 2023
pituitary
klinefelter syndrome
secondary hypogonadism
idiopathic hypogonadotropic hypogonadism
kisspeptin

Summary

The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with idiopathic hypogonadotropic hypogonadism (HH).

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.
  • On the days of the inpatient study, the subjects will
  • Day 1: Undergo q10 min blood sampling for 13 hours
  • Receive 3 kisspeptin intravenous (IV) boluses
  • Receive 1 Gonadotropin Releasing Hormone (GnRH) IV bolus
  • Day 2: Undergo q10 min blood sampling for 13 hours
  • Receive a naloxone bolus followed by a naloxone infusion
  • Receive 3 kisspeptin IV boluses
  • Receive 1 GnRH IV bolus

Details
Condition Hypogonadotropic Hypogonadism
Treatment GnRH, naloxone, kisspeptin, GnRH, naloxone
Clinical Study IdentifierNCT04975334
SponsorStephanie B. Seminara, MD
Last Modified on3 April 2023

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