Opioid Antagonism in Hypogonadotropic Hypogonadism

NCT04975334 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 313510
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Low Testosterone; Hypogonadotropic Hypogonadism

Keywords

Hypogonadotropic Hypogonadism; naloxone

Outcome Measures

Primary Outcomes (1)

• Average Change in Mean Luteinizing Hormone (LH) Value

  Change in mean LH before vs. after naloxone bolus

  Before and after treatment

Study Arms (1)

naloxone

EXPERIMENTAL

one period of frequent blood sampling with IV administration of naloxone (one bolus)

Drug: Naloxone

Interventions

Naloxone DRUG

One bolus of naloxone

naloxone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephanie B. Seminara, MD: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Stephanie Seminara
• Organization: Massachusetts General Hospital

MGHKisspeptinResearch@partners.org

617-726-1309

Study Officials

• Stephanie Seminara, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 23, 2021
• Study Start: June 18, 2025
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)