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

Acerus Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Male Hypogonadism

Treatments

Drug: Testosterone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01446042

TBS-1-2011-03

Details and patient eligibility

About

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

Full 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.

Enrollment

306 patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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