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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01446042
Recruitment Status : Unknown
Verified June 2012 by Acerus Pharmaceuticals Corporation.
Recruitment status was:  Active, not recruiting
First Posted : October 4, 2011
Last Update Posted : June 14, 2012
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Male Hypogonadism Drug: Testosterone Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: TBS-1 - b.i.d. Drug: Testosterone
Intranasal testosterone
Experimental: TBS-1 - t.i.d. Drug: Testosterone
Intranasal testosterone

Primary Outcome Measures :
  1. Serum testosterone Cavg [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Safety and tolerability of TBS-1 [ Time Frame: 90 days, 180 days, 360 days ]
  2. Effect of TBS-1 on body composition [ Time Frame: 90 days ]
  3. Effect of TBS-1 on bone mineral density [ Time Frame: 90 days ]
  4. Effect of TBS-1 on mood [ Time Frame: 90 days ]
  5. Effect of TBS-1 on erectile function [ Time Frame: 90 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01446042

  Show 30 Study Locations
Sponsors and Collaborators
Acerus Pharmaceuticals Corporation
Study Director: Natalia Tkachenko, MD Trimel Pharmaceuticals Corporation

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Acerus Pharmaceuticals Corporation Identifier: NCT01446042     History of Changes
Other Study ID Numbers: TBS-1-2011-03
First Posted: October 4, 2011    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents