Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

Multicenter study consisting of two study periods as follows: a 90-day Treatment Period, with potential extension by 30 days for those patients requiring a dose increase, as determined by the treating physician. Participants receiving 122.5mg of NATESTO (5.5 mg of testosterone) per nostril twice daily may have an increased daily dose adjustment on Day 90, based on their hypogonadism symptoms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acerus Pharmaceuticals Corporation
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Hypogonadal male between 18 and 65 years of age, inclusive;

• Able to understand and provide signed informed consent;

• Have documented total serum testosterone levels ≤300 ng/dL;

• Are currently being treated with any form of a topical testosterone replacement therapy for at least three months, or are treatment-naive.

Exclusion Criteria:

• In the opinion of the Investigator, significant intercurrent disease of any type, in particular liver, kidney, heart disease, stroke, or psychiatric illness;

• History of pituitary or hypothalamic tumors or history of any malignancy (including breast and prostate cancers) excluding basal cell or squamous cell carcinoma of the skin curatively treated by surgery;

• Prostatomegaly or history of abnormal PSA levels (>10.0 ng/mL). If PSA is >10 ng/mL, a recent negative biopsy must be documented (within the last 12 months);

• History of nasal disorders, nasal or sinus surgery, nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum surgery, mucosal inflammatory disorders, specifically Sjogren's syndrome;

• Use of any form of intranasal medication delivery other than periodic short-term (less than 3 days) use of sympathomimetic decongestants;

• History of severe adverse drug reactions to testosterone therapies;

• History or current evidence of abuse of alcohol or any drug substance;

• Current treatment with other androgens (e.g., dehydroepiandrosterone [DHEA]), anabolic steroids, or other sex hormones;

• Treatment with estrogens, gonadotropin-releasing hormone (GnRH) agonists, or growth hormone within the previous 12 months;

• Treatment with drugs that interfere with the metabolism of testosterone, such as anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, or testolactone;

• Poor compliance history;

• Participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study.