Skip to main content
OpenTrials
Completed

NCT Number: NCT04975334

Opioid Antagonism in Hypogonadotropic Hypogonadism

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

naloxone

Drug

One bolus of naloxone

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Stephanie B. Seminara, MD

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2021
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.