Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-01 @ 9:26 AM
Study NCT ID:
NCT04558567
Status:
COMPLETED
Last Update Posted:
2024-10-18
First Post:
2020-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vogelxo(R) ABPM Study in Hypogandal Men
Sponsor:
Upsher-Smith Laboratories
Organization:
Study Overview
Official Title:
A Phase 4, Open-Label, Single-Arm Study to Evaluate the Effects of Vogelxo(R) on 24-hour Ambulatory Blood Pressure Monitoring in Hypogonadal Men Using Therapeutic Testosterone Replacement Therapy
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 4 ABPM study in Hypogonadal Men
Detailed Description:
A single-arm, open-label, uncontrolled study consisting of a 4-week screening phase, 4-week titration phase, and 16-week treatment phase.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: