Conditions: Male Hypogonadism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 306
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy (based on the pharmacokinetic profile of testosterone) and safety of TBS-1 in the treatment of hypogonadal men

Detailed description:
This study is a 4 Period study consists of 16 visits with overnight clinic stays that span over year to help determine the efficacy of TBS-1 gel administered twice daily (b.i.d) and three times daily (t.i.d)

In addition, this study will investigate the safety and tolerability of TBS-1 after 90, 180 and 360 days of treatment.

Arms:
arm 1: 5.5 mg per nostril of 4.5% TBS-1 BID arm 2: 5.5 mg per nostril of 4.5% TBS-1 TID

Interventions: intervention 1: Testosterone intervention 2: Testosterone
Intervention descriptions: intervention 1: Intranasal testosterone intervention 2: Intranasal testosterone

Protocol document: