Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
NCT ID: NCT01446042
Last Updated: 2018-06-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
306 participants
INTERVENTIONAL
2011-09-30
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of an Intranasal Testosterone Product
NCT01252745
Efficacy and Tolerability of an Intra-Nasal Testosterone Product
NCT00975650
Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
NCT02159469
A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections
NCT04439799
NASOBOL in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers
NCT00647868
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In addition, this study will investigate the safety and tolerability of TBS-1 after 90, 180 and 360 days of treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TBS-1 - b.i.d.
5.5 mg per nostril of 4.5% TBS-1 BID
Testosterone
Intranasal testosterone
TBS-1 - t.i.d.
5.5 mg per nostril of 4.5% TBS-1 TID
Testosterone
Intranasal testosterone
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Testosterone
Intranasal testosterone
Testosterone
Intranasal testosterone
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* Presence of human immunodeficiency virus infection or antibodies
* History of asthma and ongoing asthma treatment
* History of sleeping problems or a shift worker
* Smoker of \>10 cigarettes (or equivalent) per day
* Regular consumption of more than 4 units of alcohol daily (1 unit is defined as 300 mL of beer, 1 glass of wine, or 1 measure of spirit) or difficulty abstaining from alcohol during the 48 hours prior to the 24 hour blood sampling visits
* History or current evidence of abuse of alcohol or any drug substance, licit or illicit, or positive urine drug and alcohol screen
* Treatment with androgen therapy within at least 2 weeks prior to baseline evaluations (subjects on androgen therapy will require a washout period of 4 weeks for depot products administered intramuscularly \[eg, testosterone enanthate 200 mg/mL\] and 2 weeks for products administered orally or topically \[oral, patch, gel, or buccal\])
* Current treatment with other androgens (eg, dehydroepiandrosterone \[DHEA\]), anabolic steroids, or other sex hormones
* Treatment with estrogens, gonadotropin-releasing hormone (GnRH) agonists, or growth hormone within previous 12 months
* Treatment with drugs that interfere with the metabolism of testosterone, such as anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, or testolactone
* Treatment with any antihypertensive, antidepressant, tranquilizer, or histamine 2 (H2) receptor blocker that is not part of a stable regimen (stable dose for at least 3 months prior to baseline);
* Poor compliance history or low likelihood of maintaining attendance
* Participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study or blood donation at any time during this study and within the 12 week period prior to screening
18 Years
80 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Acerus Pharmaceuticals Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Natalia Tkachenko, MD
Role: STUDY_DIRECTOR
Trimel Pharmaceuticals Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alabama Clinical Therapeutics LLC
Birmingham, Alabama, United States
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Coastal Clinical Research
Mobile, Alabama, United States
Quality of Life Medical Research Center
Tucson, Arizona, United States
SC Clinical Research Inc
Garden Grove, California, United States
Diablo Clinical Reseach Inc.
Walnut Creek, California, United States
Innovative Research of West Florida
Clearwater, Florida, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Pharmax Research Clinic
Miami, Florida, United States
Compass Research East LLC
Oviedo, Florida, United States
Central Kentucky Research Associates
Lexington, Kentucky, United States
Commonwealth Biomedical Research LLC
Madisonville, Kentucky, United States
Regional Urology LLC
Shreveport, Louisiana, United States
Center for Pharmaceutical Research
Kansas City, Missouri, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Rochester Clinical Research
Rochester, New York, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
The Clinical Trial Center
Jenkintown, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Coastal Carolina Research Center Inc
Mt. Pleasant, South Carolina, United States
Austin Center for Clinical Research
Austin, Texas, United States
Reseach Across America
Dallas, Texas, United States
Centex Research
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Cetero Research
San Antonio, Texas, United States
Granger Medical Clinic
West Valley City, Utah, United States
National Clinical Research - Norfolk
Norfolk, Virginia, United States
National Clinical Research
Richmond, Virginia, United States
Capital Clinical Reseach Center
Olympia, Washington, United States
Rainier Clinical Research Center
Renton, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TBS-1-2011-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.