Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 374 for:    Natesto

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03203681
Recruitment Status : Completed
First Posted : June 29, 2017
Results First Posted : August 23, 2021
Last Update Posted : October 19, 2021
Sponsor:
Collaborator:
Acerus Pharmaceuticals Corporation
Information provided by (Responsible Party):
Ranjith Ramasamy, MD, University of Miami

Brief 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.

Condition or disease Intervention/treatment Phase
Hypogonadism, Male Drug: Natesto Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Natesto
Participants in this group will receive Natesto for a 24 consecutive weeks treatment course.
Drug: Natesto
4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.




Primary Outcome Measures :
  1. Change in Testosterone Levels From Baseline to 27 Weeks [ Time Frame: Baseline, 27 Weeks ]
    Testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw

  2. Change in Estradiol Levels From Baseline to 27 Weeks [ Time Frame: Baseline, 27 Weeks ]
    Estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw

  3. Change in Gonadotropin Levels From Baseline to 27 Weeks [ 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

  4. Number of Participants With an Increase in SF-36 QOL Scores From Baseline [ Time Frame: 27 Weeks ]
    The number of participants with an increase of at least 1 point from their SF-36 QOL scores from baseline will be reported. 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

  5. Change in Sperm Counts From Baseline to 27 Weeks [ Time Frame: Baseline, 27 Weeks ]
    Sperm count measured in million sperm/mL analyzed from semen sample

  6. Incidence of Adverse Events [ Time Frame: 27 Weeks ]
    Incidence of adverse events as assessed per treating physician



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Acerus Pharmaceuticals Corporation
Investigators
Layout table for investigator information
Principal Investigator: Ranjith Ramasamy, MD University of Miami
  Study Documents (Full-Text)

Documents provided by Ranjith Ramasamy, MD, University of Miami:
Publications:
Layout table for additonal information
Responsible Party: Ranjith Ramasamy, MD, Director of Male Reproductive Medicine and Surgery/Assistant professor in Department of Urology at University of Miami, University of Miami
ClinicalTrials.gov Identifier: NCT03203681    
Other Study ID Numbers: 20170462
First Posted: June 29, 2017    Key Record Dates
Results First Posted: August 23, 2021
Last Update Posted: October 19, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Methyltestosterone
Testosterone 17 beta-cypionate
Testosterone undecanoate
Testosterone enanthate
Hypogonadism
Eunuchism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgens