MedTrace Logo

Efficacy of an Intranasal Testosterone Product

NCT01252745 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-05-23

Study results available
· View outcomes & findings →

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

Conditions

  • Hypogonadism

Interventions

DRUG

10.0 mg of Testosterone, 4.0% TID

DRUG

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

DRUG

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

Sponsors & Collaborators

  • Acerus Pharmaceuticals Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01252745 on ClinicalTrials.gov