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
Overview
- Phase
- Phase 3
- Intervention
- Testosterone
- Conditions
- Male Hypogonadism
- Sponsor
- Acerus Pharmaceuticals Corporation
- Enrollment
- 306
- Locations
- 30
- Primary Endpoint
- Serum Testosterone Cavg
- Status
- Completed
- Last Updated
- 7 years ago
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.
Investigators
Eligibility Criteria
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
TBS-1 - t.i.d.
5.5 mg per nostril of 4.5% TBS-1 TID
Intervention: Testosterone
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)