Conditions: Adult Male Hypogonadism
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 160
Healthy volunteers: no

Brief summary:
This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.

Detailed description:

Arms:
arm 1: Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.

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

Protocol document: