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

Hypogonadism Clinical Trial

Official title:

A 24-hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Treated With Natesto Nasal Testosterone Gel

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976595
• Other study ID #: NAT-2020-01
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: July 2022
• Source: Acerus Pharmaceuticals Corporation
• Contact: Dr. C. Sorli Chief Medical Officer
• Phone: +1 289 326 5762
• Email: csorli[@]aceruspharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hypogonadism

Intervention

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

Locations

Country	Name	City	State
United States	North Austin Urology	Austin	Texas
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Excel Medical Clinical Trials	Boca Raton	Florida
United States	Florida Healthcare Associates	Boynton Beach	Florida
United States	Lynn Institute of the Rockies	Colorado Springs	Colorado
United States	Coastal Bend Clinical Research	Corpus Christi	Texas
United States	Premier Urology Group	Edison	New Jersey
United States	Investigative Clinical Research of Indiana	Elwood	Indiana
United States	Prime Revival Research Institute	Flower Mound	Texas
United States	AccuMed Research Associates	Garden City	New York
United States	ProHEALTH Care Associates	Garden City	New York
United States	Baylor College of Medicine	Houston	Texas
United States	Urology of Indiana	Indianapolis	Indiana
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Preferred Research Partners	Little Rock	Arkansas
United States	Tandem Clinical Research GI, LLC	Marrero	Louisiana
United States	New Horizon Research Center	Miami	Florida
United States	University of Miami	Miami	Florida
United States	NanoHealth Associates	Miami Beach	Florida
United States	NYU Langone Health	New York	New York
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Valley Clinical Trials	Northridge	California
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Horizon Clinical Research Associates	Phoenix	Arizona
United States	Urology Center of Florida	Pompano Beach	Florida
United States	Warren Alpert School of Medicine Brown University	Providence	Rhode Island
United States	Precision Clinical Research	Sunrise	Florida
United States	Eclipse Clinical Research	Tucson	Arizona
United States	Crossroads Clinical Research	Victoria	Texas
United States	The Research Foundation for the State University of New York at Buffalo	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Acerus Pharmaceuticals Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP)		Baseline (Day 0) up to Day 120
Secondary	Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP)		Baseline (Day 0) up to Day 120
Secondary	Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP)		Baseline (Day 0) up to Day 120
Secondary	Change From Baseline in 24-hour Average Pulse Pressure		Baseline (Day 0) up to Day 120
Secondary	Change From Baseline in 24-hour Average Heart Rate		Baseline (Day 0) up to Day 120
Secondary	Change From Baseline in Hourly Average Mean Arterial Pressure (MAP)		Baseline (Day 0) up to Day 120
Secondary	Change From Baseline in Hourly Average Systolic Blood Pressure (SBP)		Baseline (Day 0) up to Day 120
Secondary	Change From Baseline in Hourly Average Diastolic Blood Pressure (DBP)		Baseline (Day 0) up to Day 120
Secondary	Change From Baseline in Hourly Average Pulse Pressure		Baseline (Day 0) up to Day 120
Secondary	Change From Baseline in Hourly Average Heart Rate		Baseline (Day 0) up to Day 120
Secondary	Percentage of Participants With New Anti-hypertensive Medications		Baseline (Day 0) up to Day 120
Secondary	Percentage of Participants With Dose Increases in Anti-hypertensive Medications		Baseline (Day 0) up to Day 120