Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
- Registration Number
- NCT01446042
- Lead Sponsor
- Acerus Pharmaceuticals Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 306
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TBS-1 - t.i.d. Testosterone 5.5 mg per nostril of 4.5% TBS-1 TID TBS-1 - b.i.d. Testosterone 5.5 mg per nostril of 4.5% TBS-1 BID
- Primary Outcome Measures
Name Time Method Serum Testosterone Cavg 90 days The percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300 to 1050 ng/dL)
- Secondary Outcome Measures
Name Time Method Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90 90 days To determine the efficacy of 4.5% TBS-1 gel, administered 2 or 3 times daily at a dose of 5.5 mg per nostril, in achieving the following serum total testosterone maximum concentration (Cmax) on Day 90:
* A Cmax (maximum testosterone concentration) value of 1500 ng/dL or more in at least 85% of the participants analyzed
* A Cmax (maximum testosterone concentration) value of 1800 to 2500 ng/dL in fewer than 5% of participants analyzed
* No analyzed participants with a Cmax (maximum testosterone concentration) \>2500 ng/dL
Trial Locations
- Locations (30)
Coastal Clinical Research
🇺🇸Mobile, Alabama, United States
Diablo Clinical Reseach Inc.
🇺🇸Walnut Creek, California, United States
Capital Clinical Reseach Center
🇺🇸Olympia, Washington, United States
SC Clinical Research Inc
🇺🇸Garden Grove, California, United States
Quality of Life Medical Research Center
🇺🇸Tucson, Arizona, United States
Medical Affiliated Research Center, Inc.
🇺🇸Huntsville, Alabama, United States
Compass Research East LLC
🇺🇸Oviedo, Florida, United States
Central Kentucky Research Associates
🇺🇸Lexington, Kentucky, United States
Reseach Across America
🇺🇸Dallas, Texas, United States
Commonwealth Biomedical Research LLC
🇺🇸Madisonville, Kentucky, United States
Rochester Clinical Research
🇺🇸Rochester, New York, United States
Innovative Research of West Florida
🇺🇸Clearwater, Florida, United States
Coastal Carolina Research Center Inc
🇺🇸Mount Pleasant, South Carolina, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
National Clinical Research - Norfolk
🇺🇸Norfolk, Virginia, United States
Centex Research
🇺🇸Houston, Texas, United States
Granger Medical Clinic
🇺🇸West Valley City, Utah, United States
Alabama Clinical Therapeutics LLC
🇺🇸Birmingham, Alabama, United States
Pharmax Research Clinic
🇺🇸Miami, Florida, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
The Clinical Trial Center
🇺🇸Jenkintown, Pennsylvania, United States
Cetero Research
🇺🇸San Antonio, Texas, United States
Regional Urology LLC
🇺🇸Shreveport, Louisiana, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Austin Center for Clinical Research
🇺🇸Austin, Texas, United States
National Clinical Research
🇺🇸Richmond, Virginia, United States