CompletedPhase 1

Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism

United Kingdom25 participantsStarted 2016-11-03

Plain-language 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 and tolerability of DITEST in the target population.

Who can participate

Age range

18 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Testosterone serum concentrations - Peak Plasma Concentration (Cmax)

Timeframe: 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))

Timeframe: 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)

Trial details

NCT IDNCT02966652

SponsorNeurocrine UK Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-04

View on ClinicalTrials.gov More Male Hypogonadism trials