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Can a pill replace shots for low testosterone?

NCT ID NCT02966652

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing an oral form of native testosterone called DITEST in men with primary or secondary hypogonadism. The trial measures how much testosterone reaches the blood after a single dose, both with and without food, and compares it to an existing oral testosterone treatment. It also tracks safety and tolerability in about 25 men aged 18 to 80.

What this could mean

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

Active substance
An oral lipid formulation of native testosterone called DITEST
What this could lead to
If it works, this could lead to an oral testosterone option that avoids injections or gels for men with low testosterone.
What could go wrong
This is a small Phase 1 study focused on blood levels and safety, not on whether symptoms improve. Oral testosterone can be hard on the liver and may not absorb consistently, especially with food.

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

25 people

The number who actually took part.

Started

Nov 2016

Finished

Oct 2018

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 80 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 Criteria: * Male subjects aged 18 to 80 years. * Diagnosis of primary testicular failure or secondary hypogonadism due to known pituitary disease or congenital deficit. * Body mass index (BMI) \>18kg/m2 and \<35kg/m2 * Testosterone level \<8nmol/L after washout of current testosterone treatment, if applicable. * Normal prostate specific antigen (PSA) levels based on the age of the subject. * Provision of written informed consent and able to participate in the study and abide by the study restrictions. Exclusion Criteria: * Subjects with a past history of, or current prostate cancer, male breast cancer or hepatic neoplasm. * Subjects with a history of or current myocardial infarction (MI), unstable cardiovascular disease, or clinically relevant findings on the screening electrocardiogram (ECG) (as determined by the investigator) * Subjects with a history of or current alcohol abuse (consumption of more than 28 units per weekweek: 1 unit equals 25mL single measure of whisky (ABV 40%), a third of a pint of beer (ABV 5-6%) or half a standard (175 mL) glass of red wine (ABV 12%). * Subjects with other unstable or inadequately treated endocrine conditions. * Haematocrit levels \>0.5 at baseline * Subjects with poor dental hygiene that would interfere with the collection of saliva samples or contaminate them with blood. * Subjects with any severe co-morbidity or with any significant medical or psychiatric conditions that in the opinion of the investigator would preclude participation in the trial. * Participation in another clinical trial or an investigation or licensed drug or device within the 3 months prior to inclusion in this study. * Allergic to any of the ingredients in the DITEST capsule, particularly sesame oil, or to any components of testosterone undecanoate capsules, particularly castor oil. * Subjects with a known intolerance to alcohol (e.g. flushing) or ethnic populations at high risk of alcohol dehydrogenase (ADH) enzyme polymorphism with potential to impair metabolism of benzyl alcohol and ethanol, both of which are contained in the DITEST formulation. * Meeting any of the contraindications for testosterone undecanoate, as detailed in the Summary of Product Characteristics (SmPC) of the comparator product. * Subjects who are unable to consume the standard high-fat breakfast. * Subjects who have donated blood or plasma in the previous 3 months prior to screening. * Any subjects taking a concomitant medication known to enhance or inhibit the action of p450 CYP3A4 (rifampicin, barbiturates, carbamazepine, dichloralphenazone, phenylbutazone, phenytoin or primidone).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Sheffield Teaching Hospital - Royal Hallamshire Hospital

    Sheffield, England, S10 2JF, United Kingdom

More trials for these conditions

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