A 90-Day, Randomized, Dose-Ranging Study, Including Potential Dose Titration, Evaluating the Efficacy and Safety of Intranasal TBS-1 in the Treatment of Male Hypogonadism With Sequential Safety Extension Periods of 90 and 180 Days
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 306
- Locations
- 30
- Primary Endpoint
- Serum Testosterone Cavg
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
TBS-1 - b.i.d.
5.5 mg per nostril of 4.5% TBS-1 BID
Intervention: Testosterone (Drug)
TBS-1 - t.i.d.
5.5 mg per nostril of 4.5% TBS-1 TID
Intervention: Testosterone (Drug)
Outcomes
Primary Outcomes
Serum Testosterone Cavg
Time Frame: 90 days
The percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300 to 1050 ng/dL)
Secondary Outcomes
- Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90(90 days)