Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism

Completed · Phase 3

Conditions studied: Male Hypogonadism

In brief

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

Key facts

Study ID

NCT01446042

Run by

Acerus Pharmaceuticals Corporation

People needed

306

Starts

2011-09-01

Expected to finish

2013-03-01

Last updated by the study team

2018-06-13

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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