CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Oral testosterone undecanoate (TU) (300 mg T equivalents/dose) +3 moredrug
Likely dose
Oral testosterone undecanoate (TU) (300 mg T equivalents/dose)from 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/NCT00695110
NCT00695110Phase 2Completed
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Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

Clarus Therapeutics, Inc.·interventional·Posted Jun 11, 2008·Updated Jun 25, 2021

In Brief

A Phase 2 clinical trial evaluating Oral testosterone undecanoate (TU) (300 mg T equivalents/dose), Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose), and 2 other interventions for Hypogonadism. Completed, enrolled 29 participants across 4 sites.

Detailed Summary

The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.

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 PostedJun 11, 2008
Enrollment StartJun 1, 2008
Primary CompletionDec 1, 2008
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.1 years ago

Interventions

Oral testosterone undecanoate (TU) (300 mg T equivalents/dose)drug

Three capsules each containing 100 mg testosterone (T) as TU, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.

Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose)drug

Two capsules each containing 100 mg T as TU and 100 mg T as TE, BID. 400 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.

Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food)drug

Two capsules each containing 100 mg T as TU, BID for 8 days. 200 mg T equivalents BID 30 minutes after initiation of meals (breakfast and dinner), except for Day 8 when the morning dose was administered fasting. A 7-14 day washout period occurred between successive Treatment Periods.

Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)drug

Two capsules each containing 150 mg T as TU and 150 mg T as TE, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days.