Male Hypogonadism Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01446042 -
Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
|
Phase 3 | |
Completed |
NCT01228071 -
Time to Eugonadal Range, Time to Steady State and Drying Time
|
Phase 3 | |
Withdrawn |
NCT02715713 -
Autonomic Manifestations of Testosterone Deficiency in Men
|
N/A | |
Completed |
NCT00858650 -
Registry of Hypogonadism in Men
|
N/A | |
Recruiting |
NCT05541172 -
Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism
|
||
Not yet recruiting |
NCT04704141 -
Relationship of the Microenvironment and Male Fertility
|
||
Completed |
NCT01403116 -
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
|
Phase 3 | |
Completed |
NCT00911586 -
Pharmacokinetic Study to Determine Time to Steady-state
|
Phase 2 | |
Completed |
NCT00924612 -
Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation
|
Phase 2 | |
Completed |
NCT01765179 -
Safety and Efficacy Trial of Testosterone Undecanoate
|
Phase 3 | |
Completed |
NCT00475501 -
5-Alpha Reductase and Anabolic Effects of Testosterone
|
Phase 2 | |
Completed |
NCT04708249 -
D-chiroinositol Administration in Hypogonadal Males
|
N/A | |
Completed |
NCT02081300 -
Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
|
Phase 3 | |
Active, not recruiting |
NCT03721497 -
Testosterone in Bariatric Patients
|
Phase 4 | |
Completed |
NCT01699178 -
Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men
|
Phase 3 |