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Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters

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ClinicalTrials.gov Identifier: NCT03203681
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ranjith Ramasamy, University of Miami

June 22, 2017
June 29, 2017
November 6, 2017
October 27, 2017
May 1, 2018   (Final data collection date for primary outcome measure)
  • Semen analysis [ Time Frame: 6 months ]
    Semen analysis measures the quantity and quality of the fluid released during ejaculation. It evaluates the seminal fluid, and the microscopic sperm. Parameters included sperm count, motility, morphology, volume, color, PH, total of motile spermatozoa.
  • Clinical laboratory assessment. Testosterone hormone [ Time Frame: 6 months ]
    Testosterone is the primary male sex hormone and an anabolic steroid. In men, testosterone plays a key role in the development of male reproductive tissues such as the testis and prostate. it is necessary for normal sperm development.
  • Clinical laboratory assessment. Follicle Stimulate Hormone (FSH) [ Time Frame: 6 months ]
    FSH stimulates testicular growth and enhances the production of an androgen-binding protein by the Sertoli cells, which are a component of the testicular tubule necessary for sustaining the maturing sperm cell.
  • Clinical laboratory assessment. Luteinizing Hormone (LH) [ Time Frame: 6 months ]
    LH stimulates testosterone production from the interstitial cells of the testes (Leydig cells).
  • Clinical laboratory assessment. Estradiol Hormone [ Time Frame: 6 months ]
    Estradiol is the predominant form of estrogen in human body and plays a critical role in male sexual function. Estradiol in men is essential for modulating libido, erectile function, and spermatogenesis
  • Sexual Health Inventory in Men (SHIM) [ Time Frame: 6 months ]
    The Sexual Health Inventory for Men (SHIM) is a widely used scale for screening and diagnosis of erectile dysfunction (ED) and severity of ED in clinical practice and research. SHIM has been adopted as a standard diagnostic aid for office screening of ED. Responses to each of the five items on the SHIM ( Table 1 ), which are based on a rating scale from 0 to 5 or from 1 to 5 , are summed to arrive at a total score that can range from 1 to 25, with higher scores indicating better sexual health. Patients with a score of 21 or less may have evidence of ED, and are encouraged to consult a physician for further evaluation and possible treatment of their condition. classification of ED is partitioned into five severity grades: no ED (SHIM total score, 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe ED (1-7).
  • Quality of life questionnaire [ Time Frame: 6 months ]
    The QOLS was originally a 15-item instrument that measured five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation. After descriptive research that queried persons with chronic illness on their perceptions of quality of life, the instrument was expanded to include one more item: Independence, the ability to do for yourself. Thus, the QOLS in its present format contains 16 items.
Same as current
Complete list of historical versions of study NCT03203681 on ClinicalTrials.gov Archive Site
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Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters
Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters
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.

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypogonadism, Male
Drug: NATESTO® (4.5% nasal testosterone) Nasal Gel
To determine the effects of 125 uL/nostril, 11.0mg testosterone/dose of Natesto on serum testosterone, LH, FSH and Semen parameters.The study will identify men with confirmed hypogonadism (testosterone (T) <350 on 2 consecutive T samples collected greater than 1.5 hours apart between 6am and 10am with demonstrated symptoms of hypogonadism). Subjects will undergo a total of six study visits. At the first visit they will undergo screening procedures which will include signing of the consent form, physical exam, assessment for inclusion and exclusion criteria, SHIM and quality of life questionnaire, blood samples ( FSH, LH, Estradiol, and Testosterone) and a semen analysis. At visit 2, second semen analysis and blood analysis for Testosterone. After 12 weeks, a third visit for blood sample and semen analysis. The subjects will also be given SHIM and quality of life questionnaires, and repeated after 25 weeks.This is a prospective case study.
NATESTO(4.5% nasal testosterone)
This is a prospective case study. Subjects will have baseline FSH, LH, Estradiol, and T before beginning therapy. Subjects will undergo a total of six study visits. At the first visit they will undergo screening procedures, At visit 2 subjects will undergo a second semen analysis and blood analysis for T. After 12 weeks, subjects will return for a third visit for blood sample and semen analysis, SHIM and quality of life questionnaires. This procedure will be repeated at week 24 to get a final blood and semen analysis
Intervention: Drug: NATESTO® (4.5% nasal testosterone) Nasal Gel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Same as current
October 1, 2018
May 1, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact: Manuel Molina, MD 305-243-4873 ext 1176 mxm2220@med.miami.edu
United States
 
 
NCT03203681
20170462
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
Ranjith Ramasamy, University of Miami
University of Miami
Not Provided
Principal Investigator: Ranjith Ramasamy, MD University of Miami
University of Miami
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP