CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 57 enrolled
Drug / intervention
Nasobol® +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/NCT00975650
NCT00975650Phase 2Completed
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Efficacy and Tolerability of Nasobol®, an Intra-Nasal Testosterone Product, for Testosterone Replacement in Hypogonadal Men

Acerus Pharmaceuticals Corporation·interventional·Posted Sep 11, 2009·Updated Aug 13, 2018

In Brief

A Phase 2 clinical trial evaluating Nasobol® and Androderm® (Positive Control) for Hypogonadism. Completed, enrolled 57 participants across 6 sites.

Detailed Summary

This clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 11, 2009
Enrollment StartAug 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.8 years ago

Interventions

Nasobol®drug

Intra-nasal Testosterone (2 syringes), b.i.d.

Androderm® (Positive Control)drug

QD administration