CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Oral Testosterone Undecanoatedrug
Likely dose
Oral Testosterone Undecanoate 158 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02670343
NCT02670343Phase 2Completed
CompareCT.gov

Evaluation of Blood Collection Methodology Following Administration of a Single-Dose of an Oral Testosterone Undecanoate Formulation In Hypogonadal Men

Clarus Therapeutics, Inc.·interventional·Posted Feb 1, 2016·Updated Mar 9, 2018

In Brief

A Phase 2 clinical trial evaluating Oral Testosterone Undecanoate for Hypogonadism. Completed, enrolled 8 participants across 1 site.

Detailed Summary

An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a single study site. Each study participant received a single oral TU dose immediately prior to a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 1, 2016
Enrollment StartJan 1, 2016
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.4 years ago

Interventions

Oral Testosterone Undecanoatedrug

Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.