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

NCT03203681 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20170462
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism, Male

Outcome Measures

Primary Outcomes (6)

• Change in Testosterone Levels From Baseline to 27 Weeks

  Testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw

  Baseline, 27 Weeks

• Change in Estradiol Levels From Baseline to 27 Weeks

  Estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw

  Baseline, 27 Weeks

• Change in Gonadotropin Levels From Baseline to 27 Weeks

  Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) levels, both measured in mIU/mL analyzed from peripheral venous puncture blood draw

  Baseline, 27 Weeks

• Number of Participants With an Increase in SF-36 QOL Scores From Baseline

  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

  27 Weeks

• Change in Sperm Counts From Baseline to 27 Weeks

  Sperm count measured in million sperm/mL analyzed from semen sample

  Baseline, 27 Weeks

• Incidence of Adverse Events

  Incidence of adverse events as assessed per treating physician

  27 Weeks

Study Arms (1)

Natesto

OTHER

Participants in this group will receive Natesto for a 24 consecutive weeks treatment course.

Drug: Natesto

Interventions

Natesto DRUG

4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.

Natesto

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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:
• Baseline hemoglobin \< 11.5 g/dL or \> 16 g/dL
• Hematocrit \< 35% or \> 54%
• Serum transaminases \> 2.5 times upper limit of normal
• Serum bilirubin \> 2.0 mg/dL
• 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.

Sponsors & Collaborators

• University of Miami: lead
• Acerus Pharmaceuticals Corporation: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (6)

• Amory JK, Anawalt BD, Blaskovich PD, Gilchriest J, Nuwayser ES, Matsumoto AM. Testosterone release from a subcutaneous, biodegradable microcapsule formulation (Viatrel) in hypogonadal men. J Androl. 2002 Jan-Feb;23(1):84-91. doi: 10.1002/jand.2002.23.1.84.

  PMID: 11780927 BACKGROUND

• Haring R, Ittermann T, Volzke H, Krebs A, Zygmunt M, Felix SB, Grabe HJ, Nauck M, Wallaschofski H. Prevalence, incidence and risk factors of testosterone deficiency in a population-based cohort of men: results from the study of health in Pomerania. Aging Male. 2010 Dec;13(4):247-57. doi: 10.3109/13685538.2010.487553. Epub 2010 May 26.

  PMID: 20504090 BACKGROUND

• Kim ED, McCullough A, Kaminetsky J. Oral enclomiphene citrate raises testosterone and preserves sperm counts in obese hypogonadal men, unlike topical testosterone: restoration instead of replacement. BJU Int. 2016 Apr;117(4):677-85. doi: 10.1111/bju.13337. Epub 2015 Oct 23.

  PMID: 26496621 BACKGROUND

• Ullah MI, Riche DM, Koch CA. Transdermal testosterone replacement therapy in men. Drug Des Devel Ther. 2014 Jan 9;8:101-12. doi: 10.2147/DDDT.S43475. eCollection 2014.

  PMID: 24470750 BACKGROUND

• Rhoden EL, Morgentaler A. Risks of testosterone-replacement therapy and recommendations for monitoring. N Engl J Med. 2004 Jan 29;350(5):482-92. doi: 10.1056/NEJMra022251. No abstract available.

  PMID: 14749457 BACKGROUND

• Rogol AD, Tkachenko N, Bryson N. Natesto , a novel testosterone nasal gel, normalizes androgen levels in hypogonadal men. Andrology. 2016 Jan;4(1):46-54. doi: 10.1111/andr.12137. Epub 2015 Dec 22.

  PMID: 26695758 BACKGROUND

MeSH Terms

Conditions

Eunuchism

Interventions

Natesto

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Ranjith Ramasamy
• Organization: University of Miami

ramasamy@miami.edu

3052433670

Study Officials

• Ranjith Ramasamy, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Male Reproductive Medicine and Surgery/Assistant professor in Department of Urology at University of Miami

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 29, 2017
• Study Start: October 27, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 19, 2021
• Results First Posted: August 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)