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

Male Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446042
• Other study ID #: TBS-1-2011-03
• Status: Completed
• Phase: Phase 3
• Start date: September 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2018
• Source: Acerus Pharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• 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

Related Conditions & MeSH terms

• Hypogonadism
• Male Hypogonadism

Intervention

Drug:
• Testosterone
Intranasal testosterone
• Testosterone
Intranasal testosterone

Locations

Country	Name	City	State
United States	Austin Center for Clinical Research	Austin	Texas
United States	Alabama Clinical Therapeutics LLC	Birmingham	Alabama
United States	Innovative Research of West Florida	Clearwater	Florida
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Reseach Across America	Dallas	Texas
United States	SC Clinical Research Inc	Garden Grove	California
United States	Centex Research	Houston	Texas
United States	Clinical Trial Network	Houston	Texas
United States	Medical Affiliated Research Center, Inc.	Huntsville	Alabama
United States	The Clinical Trial Center	Jenkintown	Pennsylvania
United States	Center for Pharmaceutical Research	Kansas City	Missouri
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Central Kentucky Research Associates	Lexington	Kentucky
United States	Commonwealth Biomedical Research LLC	Madisonville	Kentucky
United States	Pharmax Research Clinic	Miami	Florida
United States	Coastal Clinical Research	Mobile	Alabama
United States	Coastal Carolina Research Center Inc	Mount Pleasant	South Carolina
United States	National Clinical Research - Norfolk	Norfolk	Virginia
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Capital Clinical Reseach Center	Olympia	Washington
United States	Compass Research East LLC	Oviedo	Florida
United States	Rainier Clinical Research Center	Renton	Washington
United States	National Clinical Research	Richmond	Virginia
United States	Rochester Clinical Research	Rochester	New York
United States	Cetero Research	San Antonio	Texas
United States	Regional Urology LLC	Shreveport	Louisiana
United States	Quality of Life Medical Research Center	Tucson	Arizona
United States	Diablo Clinical Reseach Inc.	Walnut Creek	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	Granger Medical Clinic	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Acerus Pharmaceuticals Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90	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	90 days