Phase 2CompletedAge-related condition
Efficacy, Pharmacokinetics and Safety of Testosterone
A Phase 2 Open-Label, Sequential Dose Escalation Study to Evaluate the Efficacy, Pharmacokinetics and Safety of Three Volumes (1.25, 2.50 and 3.75 mL) of Testosterone Gel 2% (FE 999303) Equivalent to 23, 46 And 70 mg of Testosterone in Hypogonadal Males
- Sponsor
- Ferring Pharmaceuticals (Industry)
- Enrolment
- 20 enrolled
- Conditions
- Testicular Hypogonadism
- Interventions
- Testosterone gel (FE 99903)
- Ages
- adults, older adults
- Registry
- NCT01370369
Full record on ClinicalTrials.gov
From the registry
This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations \< 297 ng/dL.
Primary outcomes
- Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL.
History
Last registry update
Results first posted
Primary completion
Registered
Started