CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 325 enrolled
Drug / intervention
Oral testosterone undecanoate +1 moredrug
Likely dose
Oral testosterone undecanoate 200 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/NCT01403116
NCT01403116Phase 3Completed
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Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Clarus Therapeutics, Inc.·interventional·Posted Jul 27, 2011·Updated Aug 14, 2018

In Brief

A Phase 3 clinical trial evaluating Oral testosterone undecanoate and topical testosterone gel for Male Hypogonadism. Completed, enrolled 325 participants across 30 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMale Hypogonadism
CountriesGermany, United States
CollaboratorsPharmaNet, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2011
Enrollment StartJul 1, 2011
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.9 years ago

Interventions

Oral testosterone undecanoatedrug

Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.

topical testosterone geldrug

Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.