Conditions: Adult Male Hypogonadism
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 145
Healthy volunteers: no

Brief summary:
This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.

Detailed description:

Arms:
arm 1: Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.

Interventions: intervention 1: Testosterone Gel (FE 999093)
Intervention descriptions: intervention 1: None

Protocol document: