Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism
Condition: Male Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): DITEST; Testosterone undecanoate
Intervention type(s): Drug; Drug
Intervention description(s): Lipid formulation of native oral testosterone.; Generic treatment for patients with primary or secondary male hypogonadism
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Male; Hypogonadism; Primary; Secondary; Androgen deficiency