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Opioid blockers may shed light on low testosterone mystery

NCT ID NCT04975334

Knowledge-focused Sponsor: Stephanie B. Seminara, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how a drug that blocks opioids (naloxone) affects hormone signals in the brain related to testosterone. 23 men with a condition called hypogonadotropic hypogonadism (low testosterone) took part. The goal was to understand the body's hormone control, not to treat the condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

23 people

The number who actually took part.

Started

Jun 2025

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hypogonadism hypogonadotropic hypogonadism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypogonadotropic hypogonadism Low testosterone

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.