Phase 2CompletedAge-related condition
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
- Sponsor
- Ferring Pharmaceuticals (Industry)
- Enrolment
- 20 enrolled
- Conditions
- Hypogonadal Males
- Interventions
- Testosterone Gel (FE 999303)
- Ages
- adults, older adults
- Registry
- NCT01464879
Full record on ClinicalTrials.gov
From the registry
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
Primary outcomes
- Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.
History
Last registry update
Results first posted
Primary completion
Started
Registered