SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT02036177

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Prospective, Randomized, Single Blind, Two Arms Controlled Study to Confirm the Safety and Verify Performance of the IUB™ SCu300A Intrauterine Device in Comparison to TCu380 IUD Intra-uterine Contraceptive Device

The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper. The Primary Endpoints for comparison are based on the objective and subjective parameters. The objective parameters are pregnancy rate, perforation, expulsion and mal -position rates, changes in the endometrial thickness, rate of complications such as infection and anemia and discontinuation rates after 2 years. The subjective parameters including Quality of Life (QoL) are: pain during insertion, menstrual characteristics and pain, bleeding in correlation to the bleeding pattern prior to insertion. The Secondary Endpoints are physician opinion (ease of use in insertion and removal) and subject satisfaction.

NCT02036177 To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB

2 Interventions

Name: SCu300A IUB intrauterine device

Description: Spherical copper IUD
Type: Device
Group Labels: 1

SCu300A IUB

Name: T380A IUD

Description: T-shaped copper IUD
Type: Device
Group Labels: 1

T380A copper IUD


Primary Outcomes

Measure: Pregnancy rate

Time: 24 months

Description: Perforations, expulsions, mal-position etc

Measure: Safety issues

Time: 24 months

Measure: Discontinuation rate

Time: 24 months

Description: Recording of menstrual cramping, pain and bleeding irregularities during the trial period

Measure: Patient experience

Time: 24 months

Secondary Outcomes

Description: Ease of use in insertion and removal

Measure: Physician opinion

Time: 24 months

Purpose: Other

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T380A

Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper. --- T380A ---



HPO Nodes