Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-06 @ 4:12 PM
Study NCT ID:
NCT02036203
Status:
WITHDRAWN
Last Update Posted:
2018-07-06
First Post:
2013-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Safety and Efficacy of the SCu300A IUB Compared to the TCu380 Copper IUD
Sponsor:
Ocon Medical Ltd.
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Single Blind, Two Arms Controlled Study of the Safety and Efficacy of the SCu300A IUB™ Spherical Copper Intrauterine Ball in Comparison to TCu 380 IUD Intra-uterine Contraceptive Device
Status:
WITHDRAWN
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was withdrawn prior to patients enrolment due to sponsor's decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the safety and efficacy of the IUB SCu300A spherical copper IUD compared to the standard T shaped copper IUD, the TCu380.
Participants will be followed for one year and quality of life measurements will be measured during this period as well.
Participants will be followed for one year and quality of life measurements will be measured during this period as well.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: