CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Testosterone undecanoate +1 moredrug
Likely dose
Not stated in 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/NCT02697188
NCT02697188Phase 2Completed
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Phase IIa, Pilot, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

Clarus Therapeutics, Inc.·interventional·Posted Mar 3, 2016·Updated Nov 1, 2018

In Brief

A Phase 2 clinical trial evaluating Testosterone undecanoate and Testosterone enanthate for Hypogonadism. Completed, enrolled 12 participants across 2 sites.

Detailed Summary

Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism
CountriesUnited States
CollaboratorsLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 3, 2016
Enrollment StartNov 1, 2007
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.3 years ago

Interventions

Testosterone undecanoatedrug

Single-day dose as QD or BID for 3 of 5 crossover periods

Testosterone enanthatedrug

Single-day dose for 2 of 5 crossover periods