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

Acerus Pharmaceuticals Corporation30 sites in 1 country218 target enrollmentJuly 1, 2021

ConditionsHypogonadism

InterventionsNatesto

DrugsNatesto

Overview

Phase: Phase 4
Intervention: Natesto
Conditions: Hypogonadism
Sponsor: Acerus Pharmaceuticals Corporation
Enrollment: 218
Locations: 30
Primary Endpoint: Change From Baseline in 24-Hour Systolic Blood Pressure (SBP) At Day 120
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2021

End Date

December 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Acerus Pharmaceuticals Corporation

Responsible Party

Sponsor

Eligibility 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 80 years of age, inclusive, with documented onset of hypogonadism prior to age
•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
•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\^
•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

Arms & Interventions

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.

Intervention: Natesto

Outcomes

Primary Outcomes

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

Time Frame: Baseline (Day 0) and Day 120

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

Secondary Outcomes

Change From Baseline in Hourly Average Diastolic Blood Pressure (DBP)(Baseline (Day 0) up to Day 120)
Change From Baseline in Hourly Average Pulse Pressure(Baseline (Day 0) up to Day 120)
Change From Baseline in Hourly Average Heart Rate(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)
Change From Baseline in Hourly Average Mean Arterial Pressure (MAP)(Baseline (Day 0) up to Day 120)
Change From Baseline in Hourly Average Systolic Blood Pressure (SBP)(Baseline (Day 0) up to Day 120)
Percentage of Participants With New Anti-hypertensive Medications(Baseline (Day 0) up to Day 120)
Percentage of Participants With Dose Increases in Anti-hypertensive Medications(Baseline (Day 0) up to Day 120)
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)