A Study to Monitor Ambulatory Blood Pressure Monitoring in Hypogonadal Men Treated With Nasal Testosterone Gel

NCT04976595 | Unknown Phase 4 FDA Drug

• 1 other identifier: NAT-2020-01
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 30

Brief Summary

The purpose of this study is to assess the change in 24-hour ambulatory blood pressure monitoring (ABPM) between baseline (Day 0) and Day 120 following 4 months of testosterone therapy with Natesto.

Conditions

Hypogonadism

Keywords

Hypogonadism; Gonadal Disorders; Testosterone; Hormones; Androgens; Endocrine System Diseases; Ambulatory Blood Pressure Monitoring

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in 24-Hour Systolic Blood Pressure (SBP) At Day 120

  The change from baseline (Day 0) in 24-hour SBP after 120 days of Natesto treatment will be assessed.

  Baseline (Day 0) and Day 120

Secondary Outcomes (12)

• Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP)

  Baseline (Day 0) up to Day 120

• Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP)

  Baseline (Day 0) up to Day 120

• Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP)

  Baseline (Day 0) up to Day 120

• Change From Baseline in 24-hour Average Pulse Pressure

  Baseline (Day 0) up to Day 120

• Change From Baseline in 24-hour Average Heart Rate

  Baseline (Day 0) up to Day 120

Study Arms (1)

Natesto

EXPERIMENTAL

Participants will administer Natesto, gel, intranasally, three times daily up to Day 120. A multiple-dose dispenser will be used for gel deposition into the nasal cavity.

Drug: Natesto

Interventions

Natesto DRUG

Nasal gel containing testosterone 11 mg/dose (5.5 mg/nostril) three times daily.

Also known as: Testosterone Nasal Gel

Natesto

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 80 years of age, inclusive, with documented onset of hypogonadism prior to age 65.
• Serum total testosterone \< 300 ng/dL based on 2 consecutive blood samples obtained no greater than 1-4 weeks apart between 6 and 10 AM following an appropriate washout of current androgen replacement therapy if not testosterone naive. Historical values from the past 6 months may be used.
• Testosterone Therapy naive, OR off any testosterone therapy for at least 4 months OR agree to a 4-month washout of current testosterone therapy prior to entry at Visit 1.
• Average office blood pressure measurement \<140 millimetre of mercury (mmHg) SBP -AND- \<90 mmHg DBP.
• If the participant is on an antihypertensive regimen, he has been on it for at least 4 weeks.
• 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 pre-study examinations including abnormal breast examination requiring follow-up, an abnormal ECG.
• Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score \> 19 points.
• Body mass index (BMI) ≥ 35 kg/m\^2.
• Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
• Prostate specific antigen (PSA) \> 4 ng/mL
• Hematocrit \< 35% or \> 50%
• Baseline hemoglobin \> 16 g/dL
• Hemoglobin A1C (HbA1C) \> 9.0%
• Estimated glomerular filtration rate (eGFR) \<45
• 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 except for diabetes, or renal disease.
• 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

• Acerus Pharmaceuticals Corporation: lead

Study Sites (30)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

RECRUITING

Horizon Clinical Research Associates

Phoenix, Arizona, 85295, United States

WITHDRAWN

Eclipse Clinical Research

Tucson, Arizona, 85745, United States

WITHDRAWN

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

RECRUITING

Valley Clinical Trials

Northridge, California, 91325, United States

RECRUITING

Lynn Institute of the Rockies

Colorado Springs, Colorado, 80918, United States

WITHDRAWN

Excel Medical Clinical Trials

Boca Raton, Florida, 33434, United States

RECRUITING

Florida Healthcare Associates

Boynton Beach, Florida, 33435, United States

RECRUITING

University of Miami

Miami, Florida, 33146, United States

RECRUITING

New Horizon Research Center

Miami, Florida, 33165, United States

RECRUITING

NanoHealth Associates

Miami Beach, Florida, 33140, United States

RECRUITING

Urology Center of Florida

Pompano Beach, Florida, 33060, United States

RECRUITING

Precision Clinical Research

Sunrise, Florida, 33351, United States

RECRUITING

Investigative Clinical Research of Indiana

Elwood, Indiana, 46036, United States

RECRUITING

Urology of Indiana

Indianapolis, Indiana, 46260, United States

RECRUITING

Tandem Clinical Research GI, LLC

Marrero, Louisiana, 70072, United States

RECRUITING

Advanced Biomedical Research of America

Las Vegas, Nevada, 89123, United States

RECRUITING

Premier Urology Group

Edison, New Jersey, 08837, United States

RECRUITING

ProHEALTH Care Associates

Garden City, New York, 11042, United States

RECRUITING

AccuMed Research Associates

Garden City, New York, 11530, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

The Research Foundation for the State University of New York at Buffalo

Williamsville, New York, 14221, United States

RECRUITING

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

WITHDRAWN

Warren Alpert School of Medicine Brown University

Providence, Rhode Island, 02903, United States

WITHDRAWN

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

RECRUITING

North Austin Urology

Austin, Texas, 78750, United States

WITHDRAWN

Coastal Bend Clinical Research

Corpus Christi, Texas, 78413, United States

WITHDRAWN

Prime Revival Research Institute

Flower Mound, Texas, 76201, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Crossroads Clinical Research

Victoria, Texas, 78413, United States

RECRUITING

MeSH Terms

Conditions

Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Interventions

Natesto

Central Study Contacts

Dr. C. Sorli Chief Medical Officer

CONTACT

+1 289 326 5762; csorli@aceruspharma.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 26, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)