Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: NATESTO Testosterone Nasal Gel
Intervention description: Participants will be instructed to administer 5.5 mg of testosterone (1 actuation) per nostril of NATESTO Testosterone Nasal Gel once in the morning and once in the evening (at least 6 hours apart), preferably at the same time each day for a total daily dose of 22 mg/day of testosterone. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose.
For three times daily (after Visit 4 [Day 90] if symptoms not adequately managed by a BID dose), NATESTO will be administered intranasally once in the morning, once in the afternoon and once in the evening (approximately 6-8 hours apart), preferably at the same time each day for a total daily dose of 33 mg/day of testosterone.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hypogonadism

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.
    

Eligibility 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.