NCT01464879

A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator

A Phase 2, Open-Label, Sequential Dose Escalation Study in Adult Hypogonadal Males to Evaluate the Pharmacokinetics of Three Volumes of FE 999303 (Testosterone Gel), Applied to the Shoulder/Upper Arm, Using an Applicator Compared With Hand Application

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum testosterone concentrations \<300 ng/dL. The purpose of this study is to evaluate the pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand application

Conditions

• Hypogonadal Males

Interventions

Type	Name	Description
DRUG	Testosterone Gel (FE 999303)

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-11-04
• Last updated: 2017-09-13
• Results posted: 2017-07-28

Locations

1 site across 1 country: United States