Hypogonadal men
Conditions
Interventions
Product Name: Testosterone Undecanoate (oral TU)
Product Code: Oral TU
Pharmaceutical Form: Capsule, soft
Current Sponsor code: Testosterone Undecanoate
Other descriptive name: Testosterone Undecanoat
Sponsors
CLARUS THERAPEUTICS, INC.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Male, 18 to 75 years of age, inclusive, with hypogonadism as defined by a total serum T of =300 ng/dL, collected in the morning before 10:00 AM on two occasions within one week (on separate days). (2) With adequate venous access in their left or right arm to allow collection of a number of blood samples via a venous cannula. (3) Must be naïve to androgen-replacement therapy (or washout required), be willing to temporarily cease current T treatment, or currently not be taking T treatment in order to participate in the study. (4) If on replacement therapy for hypopituitarism or multiple endocrine deficiencies, the subject must be on stable doses of thyroid hormone and adrenal replacement hormones for at least 14 days prior to enrollment. (5) Have voluntarily given written informed consent to participate in this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: (1) Oral, topical (e.g., gel or patch) or buccal T therapy within the previous one week, or intramuscular T injection of short acting duration within the previous 4 weeks. (2) Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness. (3) Subjects with recent (within 3 months) history of stroke, not including transient ischemic attack (TIA). Further exclusion criteria: protocol, section 7.3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the efficacy of oral TU in hypogonadal men for androgen replacement therapy following approximately 12 weeks (i.e., ~90 days) of continuous therapy by identifying: •The percentages of treated patients that have 24-hour average serum T concentrations (Cavg) that are between 300 and 1000 ng/dL; and, •The percentages of treated patients that have maximum serum T concentrations (Cmax) values that are (a) less than 1500 ng/dL, (b) between 1500 and 1800 ng/dL, (c) between 1800 and 2500 ng/dL, and (d) greater than 2500 ng/dL.;Secondary Objective: To assess the effectiveness of dose titration at steady-state, if needed, based upon a single serum T sample obtained at 4-6 hours post-dose. To determine the effect of the oral TU product compared with AndroGel • To confirm efficacy (i.e., consistency of serum T pharmacokinetics) of the oral TU product for up to ~365 days of continuous therapy. • To define the safety profile of the oral TU product for up to ~365 days of continuous therapy compared with transdermal T-gel. • To determine the effect of the oral TU product compared with transdermal T-gel. Further details are outlined in the protocol, section 6.;Primary end point(s): The primary efficacy endpoint of the study is the serum T concentrations at Day 90 or Day 105 for subjects randomized to oral TU.;Timepoint(s) of evaluation of this end point: Day 90 or Day 105 for subjects randomized to oral TU. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Canada, European Union, Germany, United Kingdom, United States
Contacts
Public ContactCLARUS THERAPEUTICS, INC.
CLARUS THERAPEUTICS, INC.
Outcome results
None listed