Opioid Antagonism in Hypogonadotropic Hypogonadism

Phase 2

• Conditions: Hypogonadotropic Hypogonadism
• 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 idiopathic 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:

* Period 1: Undergo q10 min blood sampling for up to 12 hours

* Period 2: Undergo q10 min blood sampling for up to 12 hours

* Receive a naloxone bolus followed by a naloxone infusion

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Study Start: 2025-05-15
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• 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 no medication administered; one period of frequent blood sampling with IV administration of naloxone (one bolus and an infusion over an up to 12-hour period.)

Primary Outcome Measures

Name	Time	Method
Average change in Luteinizing Hormone (LH) pulse frequency	Before and during treatment	Change in LH pulse frequency before and during naloxone infusion

Secondary Outcome Measures

Name	Time	Method
Average change in LH pulse amplitude	Before and during treatment	change in LH pulse amplitude before and during naloxone infusion

Trial Locations

Locations (1)

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