Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 8:22 PM
Study NCT ID:
NCT03242408
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2017-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)
Sponsor:
Lipocine Inc.
Organization:
Study Overview
Official Title:
Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.
Status:
COMPLETED
Status Verified Date:
2019-08
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:
DF
Brief Summary:
This is a multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: