Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT02483533
Status:
TERMINATED
Last Update Posted:
2019-12-10
First Post:
2015-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Extension Study to Evaluate the Post-Treatment Safety and Duration of Clinical Effect of LIPO-202
Sponsor:
Evofem Inc.
Organization:
Study Overview
Official Title:
A Double-Blind Extension Study to Evaluate the Post-Treatment Safety and Duration of Clinical Effect of LIPO-202 in Subjects Who Completed Either the LIPO-202-CL-18 or LIPO-202-CL-19 Study
Status:
TERMINATED
Status Verified Date:
2019-11
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:
LIPO-202-CL-23 is a follow-on study to evaluate the post-treatment safety and duration of clinical effect of LIPO-202 in subjects that completed either the LIPO-202-CL-18 (NCT02397499) or LIPO-202-CL-19 (NCT02398188). No risks related to treatment are anticipated as subjects will not receive additional treatment with LIPO-202 or Placebo for LIPO-202 in this follow-on study.
Detailed Description:
None
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?: