Male HypogonadismPhase 1NCT02966652
Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism
A Phase 1 study testing DITEST and Testosterone undecanoate in people with Male Hypogonadism, run by Neurocrine UK Limited at 1 site in United Kingdom.
Trial summary
DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency in men. The study was a Phase 1 clinical study in hypogonadal men, defined according to FDA and Endocrine Society Guidelines, designed to evaluate the pharmacokinetic (PK) characteristics of DITEST, and to assess the safety… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Male Hypogonadism
- What is being tested?
- DITEST and Testosterone undecanoate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Nov 2016to 4 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospital - Royal Hallamshire Hospital
Sheffield, England, S10 2JF
About this study
Official title: A Phase 1, Randomised, Open-label, 2-cohort, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Native Oral Testosterone Formulation (DITEST) in the Fed and Fasted State and Compared to Testosterone Undecanoate in Adult Men With Primary or Secondary Hypogonadism
DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency in men. The study was a Phase 1 clinical study in hypogonadal men, defined according to FDA and Endocrine Society Guidelines, designed to evaluate the pharmacokinetic (PK) characteristics of DITEST, and to assess the safety and tolerability of DITEST in the target population.
Read the detailed description
There is an unmet need for a native oral testosterone therapy for men with androgen (testosterone) deficiency. Ideally such a treatment should have reproducible PK, does not need to be taken with fatty meals, can be taken once or twice daily, and provides physiological exposure to testosterone. This Phase 1, randomised, open-label, 2-cohort, cross-over study was therefore designed to evaluate the PK characteristics of DITEST in both the fed and fasted states according to FDA guidelines, and to assess the safety and tolerability of DITEST in the target population.
The study was conducted in male subjects from 18 to 80 years of age requiring testosterone replacement therapy for primary or secondary hypogonadism. The study was a randomised, active control, single dose, 2-way cross-over study in 2 cohorts. In each cohort subjects who meet the entry criteria at screening and baseline were randomised to one of 2 sequences:
Cohort 1: single dose of 120 mg (3 x 40 mg) DITEST followed by a single dose of 80 mg (2 x 40 mg) testosterone undecanoate (TU) or a single dose of 80 mg TU followed by single dose of 120 mg DITEST. The two treatments were separated by a minimum of a 7-day washout period, with both treatments given in the fed state.
Cohort 2: single dose of 200 mg (5 x 40 mg) DITEST (fed) followed by a single dose of 200 mg DITEST (fasted) or a single dose of 200 mg DITEST (fasted) followed by single dose of 200 mg DITEST (fed). The two treatments were separated by a minimum of a 7-day washout period.
13 subjects were recruited into cohort 1 and 12 subjects were recruited into cohort 2, resulting in a total of 25 subjects being administered study medication in this study. Subjects were not recruited into Cohort 2 until the results of subjects treated in Cohort 1 had been evaluated (this review was to determine if the intended dose for Cohort 2 needed to be adjusted). No other testosterone treatments were allowed for the duration of the study (including the washout periods).
Each subject was required to attend the study centre for a minimum of either 4 or 5 visits: a screening assessment, an evaluation of baseline testosterone levels after the washout period from the subject's current medication (only for subjects currently on testosterone replacement therapy), both dosing days, and a follow-up visit at the end of the study.
- Conditions
- Male Hypogonadism
- Being tested
- DITEST, Testosterone undecanoate
- Keywords
- Male, Hypogonadism, Primary, Secondary, Androgen deficiency
- Medical subject headings
- Eunuchism, Hypogonadism, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DITESTDrug
Lipid formulation of native oral testosterone.
Testosterone undecanoateDrug
Generic treatment for patients with primary or secondary male hypogonadism
| Study group | Role | What they receive |
|---|---|---|
| Testosterone undecanoate | Active comparator | Cohort 1: single dose of 120 mg (3 x 40 mg) DITEST followed by a single dose of 80 mg (2 x 40 mg) testosterone undecanoate or a single dose of 80 mg (2 x 40 mg) testosterone undecanoate followed by single dose of 120 mg (3 x 40 mg) DITEST. The two treatments are separated by a minimum of a 7-day washout period, with both treatments given in the fed state. Receives: Drug: DITEST; Drug: Testosterone undecanoate |
| DITEST | Experimental | Cohort 2: single dose of 200 mg (5 x 40 mg) DITEST (fed) followed by a single dose of 200 mg DITEST (fasted) or a single dose of 200 mg DITEST (fasted) followed by single dose of 200 mg (5 x 40 mg) DITEST (fed). The two treatments are separated by a minimum of a 7-day washout period. Receives: Drug: DITEST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone serum concentrations - Peak Plasma Concentration (Cmax)
Testosterone serum concentrations after administration of a single dose of 120mg or 200mg DITEST and 80mg testosterone undecanoate in the fed state, as measured by the primary PK parameter of Cmax.
Measured: Study day 0 to Study Day >7 (sampling time points at -0.5, 0.25 [120mg and TU arms only], 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours post-Investigational Medicinal Product (IMP) administration, on each visit date)
Testosterone serum concentrations - Area under the serum testosterone concentration-time curve from time 0-10 (AUC(0-10))
Testosterone serum concentrations after administration of a single dose of 120mg or 200mg DITEST and 80mg testosterone undecanoate in the fed state, as measured by the primary PK parameter of AUC.
Measured: Study day 0 to Study Day >7 (sampling time points at -0.5, 0.25 [120mg and TU arms only], 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours post-IMP administration, on each visit date)
Secondary outcomes (6)
Testosterone serum concentrations - Peak serum testosterone Concentration (Cmax)
Testosterone serum concentrations after 200mg dose of DITEST in the fed and fasted states, as measured by the primary PK parameter of Cmax.
Measured: Study day 0 to Study Day >7 (sampling time points at -0.5, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours post-IMP administration, on each visit date)
Testosterone serum concentrations after 200mg dose - Area under the serum testosterone concentration-time curve (AUC 0-10)
Testosterone serum concentrations after 200mg dose of DITEST in the fed and fasted states, as measured by the primary PK parameter of AUC (0-10)
Measured: Study day 0 to Study Day >7 (sampling time points at -0.5, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours post-IMP administration, on each visit date)
Adverse events
Adverse events (AEs) observed throughout the study.
Measured: Through study completion - a maximum of 84 days.
Vital signs
Observed changes in vital signs data during the course of the study.
Measured: Through study completion - a maximum of 84 days.
Electrocardiogram (ECG)
Observed changes in ECG data during the course of the study.
Measured: Through study completion - a maximum of 84 days.
Safety Laboratory Data
Observed changes in Safety Laboratory data during the course of the study.
Measured: Through study completion - a maximum of 84 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start3 Nov 2016
- Primary completion4 Oct 2018
- Study completion4 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust, Simbec Research, Voet Consulting, EMAS Pharma, Medical Matters International Ltd, Brush Clinical Research Ltd., Manchester University NHS Foundation Trust, Covance
- Responsible party
- Sponsor
- Investigators
- J Newell-Price, MA, PhD, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966652
- Sponsor's protocol ID
- DITEST-001
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2016
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Open-label, 2-cohort, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Native Oral Testosterone Formulation (DITEST) in the Fed and Fasted State and Compared to Testosterone Undecanoate in Adult Men With Primary or Secondary Hypogonadism
- ClinicalTrials.gov ID
- NCT02966652
- Acronym / sponsor ID
- DITEST-001
- Conditions
- Male Hypogonadism
- Keywords
- Male, Hypogonadism, Primary, Secondary, Androgen deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Neurocrine UK LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust, Simbec Research, Voet Consulting, EMAS Pharma, Medical Matters International Ltd, Brush Clinical Research Ltd., Manchester University NHS Foundation Trust, Covance
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 4 Oct 2018 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency in men. The study was a Phase 1 clinical study in hypogonadal men, defined according to FDA and Endocrine Society Guidelines, designed to evaluate the pharmacokinetic (PK) characteristics of DITEST, and to assess the safety and tolerability of DITEST in the target population.
Detailed description
There is an unmet need for a native oral testosterone therapy for men with androgen (testosterone) deficiency. Ideally such a treatment should have reproducible PK, does not need to be taken with fatty meals, can be taken once or twice daily, and provides physiological exposure to testosterone. This Phase 1, randomised, open-label, 2-cohort, cross-over study was therefore designed to evaluate the PK characteristics of DITEST in both the fed and fasted states according to FDA guidelines, and to assess the safety and tolerability of DITEST in the target population.
The study was conducted in male subjects from 18 to 80 years of age requiring testosterone replacement therapy for primary or secondary hypogonadism. The study was a randomised, active control, single dose, 2-way cross-over study in 2 cohorts. In each cohort subjects who meet the entry criteria at screening and baseline were randomised to one of 2 sequences:
Cohort 1: single dose of 120 mg (3 x 40 mg) DITEST followed by a single dose of 80 mg (2 x 40 mg) testosterone undecanoate (TU) or a single dose of 80 mg TU followed by single dose of 120 mg DITEST. The two treatments were separated by a minimum of a 7-day washout period, with both treatments given in the fed state.
Cohort 2: single dose of 200 mg (5 x 40 mg) DITEST (fed) followed by a single dose of 200 mg DITEST (fasted) or a single dose of 200 mg DITEST (fasted) followed by single dose of 200 mg DITEST (fed). The two treatments were separated by a minimum of a 7-day washout period.
13 subjects were recruited into cohort 1 and 12 subjects were recruited into cohort 2, resulting in a total of 25 subjects being administered study medication in this study. Subjects were not recruited into Cohort 2 until the results of subjects treated in Cohort 1 had been evaluated (this review was to determine if the intended dose for Cohort 2 needed to be adjusted). No other testosterone treatments were allowed for the duration of the study (including the washout periods).
Each subject was required to attend the study centre for a minimum of either 4 or 5 visits: a screening assessment, an evaluation of baseline testosterone levels after the washout period from the subject's current medication (only for subjects currently on testosterone replacement therapy), both dosing days, and a follow-up visit at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone undecanoate | Active comparator | Drug: DITEST, Drug: Testosterone undecanoateCohort 1: single dose of 120 mg (3 x 40 mg) DITEST followed by a single dose of 80 mg (2 x 40 mg) testosterone undecanoate or a single dose of 80 mg (2 x 40 mg) testosterone undecanoate followed by single dose of 120 mg (3 x 40 mg) DITEST. The two treatments are separated by a minimum of a 7-day washout period, with both treatments given in the fed state. |
| DITEST | Experimental | Drug: DITESTCohort 2: single dose of 200 mg (5 x 40 mg) DITEST (fed) followed by a single dose of 200 mg DITEST (fasted) or a single dose of 200 mg DITEST (fasted) followed by single dose of 200 mg (5 x 40 mg) DITEST (fed). The two treatments are separated by a minimum of a 7-day washout period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DITESTLipid formulation of native oral testosterone. | Drug | DITEST, Testosterone undecanoate |
| Testosterone undecanoateGeneric treatment for patients with primary or secondary male hypogonadism | Drug | Testosterone undecanoate |
Primary outcome
Testosterone serum concentrations - Peak Plasma Concentration (Cmax)
Time frame: Study day 0 to Study Day >7 (sampling time points at -0.5, 0.25 [120mg and TU arms only], 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours post-Investigational Medicinal Product (IMP) administration, on each visit date)
Testosterone serum concentrations after administration of a single dose of 120mg or 200mg DITEST and 80mg testosterone undecanoate in the fed state, as measured by the primary PK parameter of Cmax.
Testosterone serum concentrations - Area under the serum testosterone concentration-time curve from time 0-10 (AUC(0-10))
Time frame: Study day 0 to Study Day >7 (sampling time points at -0.5, 0.25 [120mg and TU arms only], 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours post-IMP administration, on each visit date)
Testosterone serum concentrations after administration of a single dose of 120mg or 200mg DITEST and 80mg testosterone undecanoate in the fed state, as measured by the primary PK parameter of AUC.
6 secondary outcomes
Testosterone serum concentrations - Peak serum testosterone Concentration (Cmax)
Time frame: Study day 0 to Study Day >7 (sampling time points at -0.5, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours post-IMP administration, on each visit date)
Testosterone serum concentrations after 200mg dose - Area under the serum testosterone concentration-time curve (AUC 0-10)
Time frame: Study day 0 to Study Day >7 (sampling time points at -0.5, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours post-IMP administration, on each visit date)
Adverse events
Time frame: Through study completion - a maximum of 84 days.
Vital signs
Time frame: Through study completion - a maximum of 84 days.
Electrocardiogram (ECG)
Time frame: Through study completion - a maximum of 84 days.
Safety Laboratory Data
Time frame: Through study completion - a maximum of 84 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J Newell-Price, MA, PhD principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DITEST and Testosterone undecanoate in people with Male Hypogonadism, run by Neurocrine UK Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testosterone serum concentrations - Peak Plasma Concentration (Cmax) (time frame: Study day 0 to Study Day >7 (sampling time points at -0.5, 0.25 [120mg and TU arms only], 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours post-Investigational Medicinal Product (IMP) administration, on each visit date)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.