Can a pill replace shots for low testosterone?
NCT ID NCT02966652
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
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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
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18 to 80 years
- Sex
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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 Hide 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
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Other studies related to the condition(s) this trial covers.
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