Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-25 @ 1:37 PM
Study NCT ID:
NCT05800392
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2023-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of DEC103 in Pain Control Associated to Intrauterine Device (IUD) Insertion
Sponsor:
EMS
Organization:
Study Overview
Official Title:
A National, Single Center, Randomized, Prospective, Phase IV, Double-blind, Placebo-controlled, Parallel Study to Assess the Efficacy and Safety of DEC103 in the Pain Control Associated With Intrauterine Device (IUD) Insertion
Status:
COMPLETED
Status Verified Date:
2024-02
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:
DEC103
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of DEC103 in the pain control associated with IUD insertion in women with 18 to 49 years.
Detailed Description:
The DEC103 treatment is composed by two different medications that are already available in brazilian market. One is a sublingual pill and the other is an oral one. The participants must take 02 (two) pills of the sublingual formulation and 01 (one) of the oral formulation.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: