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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Trimel Biopharma SRL.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Trimel Biopharma SRL
ClinicalTrials.gov Identifier:
NCT01446042
First received: September 30, 2011
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Male Hypogonadism
Drug: Testosterone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Trimel Biopharma SRL:

Primary Outcome Measures:
  • Serum testosterone Cavg [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and tolerability of TBS-1 [ Time Frame: 90 days, 180 days, 360 days ] [ Designated as safety issue: Yes ]
  • Effect of TBS-1 on body composition [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Effect of TBS-1 on bone mineral density [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Effect of TBS-1 on mood [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Effect of TBS-1 on erectile function [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TBS-1 - b.i.d. Drug: Testosterone
Intranasal testosterone
Experimental: TBS-1 - t.i.d. Drug: Testosterone
Intranasal testosterone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01446042

  Show 30 Study Locations
Sponsors and Collaborators
Trimel Biopharma SRL
Investigators
Study Director: Natalia Tkachenko, MD Trimel Pharmaceuticals Corporation
  More Information

No publications provided

Responsible Party: Trimel Biopharma SRL
ClinicalTrials.gov Identifier: NCT01446042     History of Changes
Other Study ID Numbers: TBS-1-2011-03
Study First Received: September 30, 2011
Last Updated: June 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypogonadism
Eunuchism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 20, 2014