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New implant could offer steady testosterone for men with low t

NCT ID NCT07500766

Disease control Sponsor: University of Sao Paulo 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether testosterone implants placed under the skin can safely and effectively raise testosterone levels in men with low testosterone (hypogonadism). Thirty men will receive four implants and be monitored for six months. The goal is to see if this method provides steady hormone levels and improves symptoms like low energy and sexual function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
testosterone implants
What this could lead to
If successful, this could provide a more convenient and consistent testosterone replacement option for men with low testosterone, potentially improving adherence and quality of life.
What could go wrong
This is a small, early-phase study with only 30 participants. The implants may not maintain target testosterone levels, or side effects could emerge. Results may not apply to all men with hypogonadism.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

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 years and older

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 Criteria: * Absence of desire for future fertility. * Two fasting total testosterone measurements ≤ 350 ng/dL obtained between 6:00 and 10:00 a.m. * A positive ADAM questionnaire result (Participants with a prior diagnosis of testosterone deficiency established at this institution who are currently receiving testosterone replacement therapy and wish to participate in the study will be eligible for inclusion after completion of an appropriate washout period of the testosterone formulation in use.) Exclusion Criteria: * Inability to complete or respond to study questionnaires. * Body mass index (BMI) \> 35 kg/m². * Untreated depression, defined as a Beck Depression Inventory score \> 20. * Personal history of cancer. * Suspicious findings on digital rectal examination or breast examination. * Prostate-specific antigen (PSA) \> 4 ng/mL. * History of thrombosis. * Known thrombophilia. * Erythrocytosis. * Polycythemia. * Elevated liver enzymes (AST or ALT \> 1.5 times the upper limit of normal). * Untreated chronic disease. * Heart failure classified as New York Heart Association (NYHA) class III or IV. * History of cardiovascular disease within the previous 6 months. * Substance use disorder or alcohol dependence. * Use of antiandrogen medications (flutamide, bicalutamide, enzalutamide, apalutamide, spironolactone, cyproterone acetate, abiraterone, ketoconazole, dutasteride, finasteride). * Use of estrogenic medications (estradiol, conjugated estrogens, progestogens). * Use of anabolic androgenic steroids without medical indication. * Untreated hypothyroidism. * Known allergy or hypersensitivity to testosterone or any component of the implant (testosterone, stearic acid).

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Conditions

The condition(s) this trial relates to.

eunuchism hypogonadism hypogonadism, male

As listed by the trial registrant

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

Male hypogonadism Testosterone Testosterone deficiency Testosterone replacement therapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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