Opioid Antagonism in Hypogonadotropic Hypogonadism

May 16, 2026 updated by: Stephanie B. Seminara, MD
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion

  • Male
  • Age 18-75 years
  • Confirmed diagnosis of hypogonadotropic hypogonadism (low testosterone)
  • 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

Exclusion

  • Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
  • Current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis and, if applicable, unwilling to complete an appropriate washout for that particular medication and its method of administration
  • Current or recent use of a medication that affects the opioid pathway
  • Active illicit drug use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: naloxone
one period of frequent blood sampling with IV administration of naloxone (one bolus)
Drug: Naloxone
One bolus of naloxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Change in Mean Luteinizing Hormone (LH) Value
Time Frame: Before and after treatment, a 3 hour period on a single study day
Change in mean LH before vs. after naloxone bolus
Before and after treatment, a 3 hour period on a single study day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average change in LH pulse amplitude
Time Frame: Before and during treatment
change in LH pulse amplitude before and during naloxone infusion
Before and during treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stephanie B. Seminara, MD

Investigators

  • Principal Investigator: Stephanie Seminara, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2025

Primary Completion (Actual)

September 26, 2025

Study Completion (Actual)

September 26, 2025

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 16, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 313510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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