A Study to Monitor Ambulatory Blood Pressure Monitoring in Hypogonadal Men Treated With Nasal Testosterone Gel
NCT04976595 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 218
Last updated 2022-07-06
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
Interventions
- DRUG
-
Natesto
Nasal gel containing testosterone 11 mg/dose (5.5 mg/nostril) three times daily.
Sponsors & Collaborators
-
Acerus Pharmaceuticals Corporation
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-01
- Primary Completion
- 2022-12-31
- Completion
- 2022-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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