Opioid Antagonism in Hypogonadotropic Hypogonadism

Not Applicable

Recruiting

• Conditions: Hypogonadotropic Hypogonadism; Low Testosterone
• Interventions: Drug: Naloxone

• Registration Number: NCT04975334
• Lead Sponsor: Stephanie B. Seminara, MD

Brief 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

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-23
• Study Start: 2025-06-18
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-25
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
naloxone	Naloxone	one period of frequent blood sampling with IV administration of naloxone (one bolus)

Primary Outcome Measures

Name	Time	Method
Average change in mean Luteinizing Hormone (LH) value	Before and after treatment	Change in mean LH before vs. after naloxone bolus

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States