CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
10.0 mg of Testosterone, 4.0% TID +2 moredrug
Likely dose
10.0 mg of Testosterone, 4.0% TIDfrom 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/NCT01252745
NCT01252745Phase 2Completed
CompareCT.gov

An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men

Acerus Pharmaceuticals Corporation·interventional·Posted Dec 3, 2010·Updated May 23, 2018

In Brief

A Phase 2 clinical trial evaluating 10.0 mg of Testosterone, 4.0% TID, 13.5 mg of Testosterone, 4.5% B.I.D, and 1 other intervention for Hypogonadism. Completed, enrolled 22 participants across 3 sites.

Detailed Summary

This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 3, 2010
Enrollment StartAug 1, 2010
Primary CompletionNov 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.6 years ago

Interventions

10.0 mg of Testosterone, 4.0% TIDdrug

13.5 mg of Testosterone, 4.5% B.I.Ddrug

11.25 mg of Testosterone, 4.5% T.I.Ddrug