Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters
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|ClinicalTrials.gov Identifier: NCT03203681|
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : August 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism, Male||Drug: Natesto||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)|
|Actual Enrollment :||71 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|
|Actual Primary Completion Date :||June 1, 2020|
|Actual Study Completion Date :||June 1, 2020|
Participants in this group will receive Natesto for a 24 consecutive weeks treatment course.
4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.
- Change in testosterone levels [ Time Frame: Baseline, 27 Weeks ]Testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw
- Change in estradiol levels [ Time Frame: Baseline, 27 Weeks ]Estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw
- Change in gonadotropin levels [ Time Frame: Baseline, 27 Weeks ]Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) levels, both measured in mIU,mL analyzed from peripheral venous puncture blood draw
- Change in SF-36 QOL questionnaire scores [ Time Frame: Baseline, 27 Weeks ]Short Form-36 (SF-36) Quality of Life (QOL) questionnaire has a proprietary scoring system that ranges from 1-5 and each domain is individually assessed
- Change in sperm counts [ Time Frame: Baseline, 27 Weeks ]Sperm count measured in million sperm/mL analyzed from semen sample
- Incidence of adverse events [ Time Frame: 27 Weeks ]Incidence of adverse events as assessed per treating physician
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
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Ranjith Ramasamy, MD||University of Miami|