Recruiting

Nasal Testosterone Gel

Sponsor:

Acerus Pharmaceuticals Corporation

Code:

NCT04976595

Conditions

Hypogonadism

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Natesto

Study Details

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

Study ID

NCT04976595

Start date

Jul 1, 2021

Status verified date

Jul, 2022

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 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).

Exclusion Criteria:

  • 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.
  • History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
  • Currently using tobacco, e-cigarettes or other nicotine containing products.
  • History of nasal disorders such as nasal surgery; nasal trauma resulting in nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum; or sinus surgery or sinus disease.
  • Receipt of any investigational product within 4 weeks of study start.
  • Inability to understand and provide written informed consent for the study.
  • Considered by the investigator or the sponsor-designated physician, for any reason, as an unsuitable candidate to receive Natesto.
  • Participants working night-shifts.
  • Participants performing strenuous manual labor while wearing the ABPM monitor.
  • Participants with chronic atrial fibrillation (interferes with the ability to obtain precise ambulatory recordings).

Study Design

Enrollment

218 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Natesto

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.

Interventions

Natesto

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

Primary outcome measure

  • Change From Baseline in 24-Hour Systolic Blood Pressure (SBP) At Day 120 [ Time Frame: Baseline (Day 0) and Day 120 ]

Central Contacts and Locations

Central contacts

Dr. C. Sorli Chief Medical Officer

+1 289 326 5762csorli@aceruspharma.com

Locations

Alabama Clinical Therapeutics

Recruiting

Birmingham, Alabama, United States, 35235

Preferred Research Partners

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Little Rock, Arkansas, United States, 72211

Valley Clinical Trials

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Northridge, California, United States, 91325

Excel Medical Clinical Trials

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Boca Raton, Florida, United States, 33434

Florida Healthcare Associates

Recruiting

Boynton Beach, Florida, United States, 33435

NanoHealth Associates

Recruiting

Miami Beach, Florida, United States, 33140

University of Miami

Recruiting

Miami, Florida, United States, 33146

New Horizon Research Center

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Miami, Florida, United States, 33165

Urology Center of Florida

Recruiting

Pompano Beach, Florida, United States, 33060

Precision Clinical Research

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Sunrise, Florida, United States, 33351

Investigative Clinical Research of Indiana

Recruiting

Elwood, Indiana, United States, 46036

Urology of Indiana

Recruiting

Indianapolis, Indiana, United States, 46260

Tandem Clinical Research GI, LLC

Recruiting

Marrero, Louisiana, United States, 70072

Advanced Biomedical Research of America

Recruiting

Las Vegas, Nevada, United States, 89123

Premier Urology Group

Recruiting

Edison, New Jersey, United States, 08837

ProHEALTH Care Associates

Recruiting

Garden City, New York, United States, 11042

AccuMed Research Associates

Recruiting

Garden City, New York, United States, 11530

NYU Langone Health

Recruiting

New York, New York, United States, 10016

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

Recruiting

Williamsville, New York, United States, 14221

Coastal Carolina Research Center

Recruiting

North Charleston, South Carolina, United States, 29405

Prime Revival Research Institute

Recruiting

Flower Mound, Texas, United States, 76201

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Crossroads Clinical Research

Recruiting

Victoria, Texas, United States, 78413

More Information

Sponsor

Acerus Pharmaceuticals Corporation

Last update posted

Jul 6, 2022

Last verified

Jul, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Acerus Pharmaceuticals Corporation on 2022-07-06.