Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Intervention: Natesto
Intervention description: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.
Intervention MeSH terms: Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Low testosterone affects more than 10% of men worldwide, with high incidence in the
      elderly.This will be a prospective case study. The investigators will identify men with
      hypogonadism in our clinic interested in Natesto for testosterone replacement therapy (TRT).
      Natesto is a relatively new form of testosterone replacement therapy that is delivered
      intranasal to men diagnosed with low testosterone. Current advantages to Natesto include ease
      of delivery and decreased risk of transference. Recently Natesto 4.5% (125 uL/nostril, 11.0mg
      testosterone/dose), three times a day (TID) dosing was shown to also increase serum
      testosterone while maintaining normal, though decreased, serum levels of Luteinizing Hormone
      (LH) and Follicle-Stimulating Hormone(FSH). 40 participants will be enrolled and receive
      treatment with Natesto.The study will identify men with confirmed hypogonadism (testosterone
      (T) <350 on 2 consecutive Testosterone samples collected greater than 1.5 hours apart between
      6am and 10am with demonstrated symptoms of hypogonadism). Participants with a history of
      prostate cancer, testis cancer, azoospermia, or genetic cause of hypogonadism will be
      excluded.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily sign and date the study consent form(s) which have been approved by an
             Institutional Review Board (IRB). Written consent must be obtained prior to the
             initiation of any study procedures.

          -  Male between 18 and 55 years of age, inclusive, with documented onset of hypogonadism
             prior to age 55.

          -  Documented diagnosis of primary hypogonadism (congenital or acquired) or
             hypogonadotropic hypogonadism (congenital or acquired).

          -  Serum total testosterone < 350 ng/dL based on 2 consecutive blood samples obtained at
             least 1.5 hours apart between 6:00 am and 10:00 am following an appropriate washout of
             current androgen replacement therapy.

          -  Naïve to androgen replacement or has discontinued current treatment and completed a
             washout of 4 weeks following androgen treatment (excluding Testopel). Washout must be
             completed prior to collection of baseline serum testosterone samples to determine
             study eligibility.

          -  Judged to be in good general health as determined by the principal investigator based
             upon the results of a medical history, physical examination, vital signs, laboratory
             profile and a 12-lead electrocardiogram (ECG).

        Exclusion Criteria:

          -  History of significant sensitivity or allergy to androgens, castor oil or product
             excipients.

          -  Clinically significant findings in the prestudy examinations including abnormal breast
             examination requiring follow-up, abnormal ECG.

          -  Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or
             International Prostate Symptoms Score (I-PSS) > 19 points.

          -  Body mass index (BMI) ≥ 30 kg/m2.

          -  Clinically significant abnormal laboratory value, in the opinion of the investigator,
             in serum chemistry, hematology, or urinalysis including but not limited to:

               1. Baseline hemoglobin < 11.5 g/dL or > 16 g/dL

               2. Hematocrit < 35% or > 54%

               3. Serum transaminases > 2.5 times upper limit of normal

               4. Serum bilirubin > 2.0 mg/dL

               5. Creatinine > 2.0 mg/dL f. Prostate-Specific Antigen (PSA) > 2 ng/mL

          -  History of seizures or convulsions, including febrile, alcohol or drug withdrawal
             seizures.

          -  History of any clinically significant illness, infection, or surgical procedure within
             4 weeks prior to study drug administration.

          -  History of stroke or myocardial infarction within the past 5 years.

          -  History of, or current or suspected, prostate or breast cancer.

          -  History of diagnosed, severe, untreated, obstructive sleep apnea.

          -  History of abuse of alcohol or any drug substance in the opinion of the investigator
             within the previous 2 years.

          -  Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt
             of a transfusion of any blood product within 12 weeks prior to the start of treatment.

          -  Inadequate venous access for collection of serial blood samples required for
             pharmacokinetic profiles.

          -  Receipt of any investigational product within 4 weeks or within 5 half-lives prior to
             the start of treatment.

          -  Inability to understand and provide written informed consent for the study.

          -  Considered by the investigator or the sponsor-designated physician, for any reason,
             that the subject is an unsuitable candidate to receive Natesto.