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 : July 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism, Male||Drug: NATESTO® (4.5% nasal testosterone) Nasal Gel||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters|
|Actual Study Start Date :||October 27, 2017|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||April 1, 2021|
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
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203681
|Contact: Manuel Molina, MD||305-243-4873 ext firstname.lastname@example.org|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Manuel Molina, MD 305-243-4873 ext 1176 email@example.com|
|Principal Investigator: Ranjith Ramasamy, MD|
|Principal Investigator:||Ranjith Ramasamy, MD||University of Miami|