Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Low testosterone affects more than 10% of men worldwide, with high incidence in the elderly).
      While Natesto has been shown to have positive effects on Testosterone while maintaining LH
      and FSH, the impact on sperm count has not yet been proven.

      Study Design and Duration of Treatment: Participants will take Natesto 11g intra nasally
      there times a day (TID) for 16 weeks (120 days) between serum and semen evaluations.

      Subject Population: 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). Subjects with a history of prostate
      cancer, testis cancer, azoospermia, or genetic cause of hypogonadism will be excluded.

      Number of subjects: 40 participants will be enrolled and receive treatment with Natesto.

      Study Duration:Total participation in the study will be approximately 24-28 weeks.

      Study Procedures: Participants will undergo a total of six study visits. At the first visit,
      subjects will undergo screening procedures which will include signing of the consent form,
      physical exam, assessment for inclusion and exclusion criteria, Sexual Health Inventory in
      Men (SHIM) and quality of life questionnaire, blood sample for clinical laboratory
      assessment, and a semen analysis. At visit 2, subjects will undergo a second semen analysis
      and blood analysis for T. After 12 weeks (90 days), Participants will return for a third
      visit for blood sample and semen analysis as well as safety monitoring. The Participants will
      also be given SHIM and quality of life questionnaires. This procedure will be repeated at
      week 24 to get a final blood and semen analysis.

      Study Endpoints: The primary endpoint will be change in FSH, LH, Estradiol, T, and Semen
      Analysis after 12 weeks and 24 weeks of treatment with Natesto. The secondary endpoint will
      be monitoring for adverse events

      Statistical Methods: Analyses will consist of summaries of the values and total change from
      baseline in each value (visit value versus baseline value) using descriptive statistics
      (sample size, mean, median, standard deviation, 95% confidence interval, minimum, and
      maximum). The change from baseline in each endpoint will compared using a two-sample t-test,
      or the Wilcoxon rank sum test if distributional assumptions are violated. The primary time
      point of interest for assessing hormone effects is the week 12 visit.
    

Intervention name(s): Natesto
Intervention type(s): Drug
Intervention description(s): 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
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment