Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-28 @ 2:16 PM
Study NCT ID:
NCT01623466
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2012-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches
Sponsor:
Agile Therapeutics
Organization:
Study Overview
Official Title:
A Randomized, Open-Label, Parallel Group Study To Evaluate Pharmacokinetic Profile, Wearability And Safety of Two Progestin-Only Patches Containing Different Doses Of Levonorgestrel (LNG)
Status:
COMPLETED
Status Verified Date:
2017-12
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:
ATI-CL21
Brief Summary:
Pharmacokinetics, safety and wearability in two size patches of AG890 over eight weeks will be evaluated.
Detailed Description:
To evaluate pharmacokinetic (PK) profile, patch wearability (adhesion and skin irritation), and safety of AG890-6.5 and AG890-12.5 TCDS.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: