Conditions: Adult Male Hypogonadism
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 180
Healthy volunteers: no

Brief summary:
This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations \<300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.

Detailed description:

Arms:
arm 1: Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.

Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.

Interventions: intervention 1: Testosterone gel (FE 999303)
Intervention descriptions: intervention 1: None

Protocol document: