Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
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
1 other identifier
interventional
306
1 country
30
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2011
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 30, 2011
CompletedFirst Posted
Study publicly available on registry
October 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
June 13, 2018
CompletedJune 13, 2018
March 1, 2018
1.3 years
September 30, 2011
February 16, 2018
May 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Serum Testosterone Cavg
The percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300 to 1050 ng/dL)
90 days
Secondary Outcomes (1)
Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90
90 days
Study Arms (2)
TBS-1 - b.i.d.
EXPERIMENTAL5.5 mg per nostril of 4.5% TBS-1 BID
TBS-1 - t.i.d.
EXPERIMENTAL5.5 mg per nostril of 4.5% TBS-1 TID
Interventions
Eligibility Criteria
You may qualify if:
- Male between 18 and 80 years of age
- Able to understand and provide signed informed consent
- Have 2 fasting morning (0900 h ± 30 min) serum total testosterone levels \<300 ng/dL
- Body mass index between 18.5 kg/m2 and 35 kg/m2
- Hemoglobin level \> or = 13.0 g/dL
- Screening laboratory assessments within ±15% of the normal range, with the exception of liver function tests (which need to be within the normal range) and HbA1c (which must be \<7.0% \[9.5 mmol/L\]); lipid profile and endocrine profile assessments are also exempt from this range unless the assessments indicate a significant intercurrent illness other than testosterone deficiency
- Ear, nose and throat examination including nasal endoscopy without clinically significant abnormal findings
- Normal prostate for age based on digital rectal exam and a serum PSA \<4.0 ng/mL.
You may not qualify if:
- Significant intercurrent disease of any type, in particular liver, kidney, heart disease, or psychiatric illness
- Hyperparathyroidism, uncontrolled diabetes mellitus, hypothyroidism, or hyperthyroidism (thyroid stimulating hormone should be \<1.5 times the upper limit of normal)
- Hematocrit \>54% at screening
- History of pituitary or hypothalamic tumors or history of malignancy within the past 5 years, excluding basal cell or squamous cell carcinoma of the skin curatively treated by surgery
- History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, "nose job," or sinus surgery
- History of nasal fractures within the past 6 months and/or prior nasal fractures that caused a severely deviated anterior nasal septum
- Active allergies, such as rhinitis, rhinorrhea, and nasal congestion
- Mucosal inflammatory disorders, specifically pemphigus or Sjogren's syndrome
- Sinus disease, specifically acute sinusitis, chronic sinusitis, or allergic fungal sinusitis
- History of nasal disorders (eg, polyposis, recurrent epistaxis \[\>1 nose bleed per month\], abuse of nasal decongestants) or sleep apnea
- Use of any form of intranasal medication delivery, specifically nasal corticosteroids and oxymetazoline-containing nasal sprays (eg, Dristan® 12-Hour Nasal Spray)
- History of severe adverse drug reaction or leukopenia
- A known hypersensitivity to lidocaine or any materials that may be used during the study
- History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation
- History of hepatitis B, a positive test for hepatitis B surface antigen, a history of hepatitis C, or a positive test for hepatitis C antibody
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Alabama Clinical Therapeutics LLC
Birmingham, Alabama, 35235, United States
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801, United States
Coastal Clinical Research
Mobile, Alabama, 36608, United States
Quality of Life Medical Research Center
Tucson, Arizona, 85712, United States
SC Clinical Research Inc
Garden Grove, California, 92844, United States
Diablo Clinical Reseach Inc.
Walnut Creek, California, 94598, United States
Innovative Research of West Florida
Clearwater, Florida, 33756, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Pharmax Research Clinic
Miami, Florida, 33126, United States
Compass Research East LLC
Oviedo, Florida, 32765, United States
Central Kentucky Research Associates
Lexington, Kentucky, 40509, United States
Commonwealth Biomedical Research LLC
Madisonville, Kentucky, 42431, United States
Regional Urology LLC
Shreveport, Louisiana, 71106, United States
Center for Pharmaceutical Research
Kansas City, Missouri, 61114, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
The Clinical Trial Center
Jenkintown, Pennsylvania, 19046, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Coastal Carolina Research Center Inc
Mt. Pleasant, South Carolina, 29464, United States
Austin Center for Clinical Research
Austin, Texas, 78756, United States
Reseach Across America
Dallas, Texas, 75234, United States
Centex Research
Houston, Texas, 77062, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Cetero Research
San Antonio, Texas, 78229, United States
Granger Medical Clinic
West Valley City, Utah, 84120, United States
National Clinical Research - Norfolk
Norfolk, Virginia, 23502, United States
National Clinical Research
Richmond, Virginia, 23294, United States
Capital Clinical Reseach Center
Olympia, Washington, 98502, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Related Publications (1)
Rogol AD, Tkachenko N, Bryson N. Natesto , a novel testosterone nasal gel, normalizes androgen levels in hypogonadal men. Andrology. 2016 Jan;4(1):46-54. doi: 10.1111/andr.12137. Epub 2015 Dec 22.
PMID: 26695758DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Natalia Tkachenko, MD Director Clinical Affairs
- Organization
- Trimel Pharmaceuticals Corp.
Study Officials
- STUDY DIRECTOR
Natalia Tkachenko, MD
Trimel Pharmaceuticals Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2011
First Posted
October 4, 2011
Study Start
September 1, 2011
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
June 13, 2018
Results First Posted
June 13, 2018
Record last verified: 2018-03