Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD
- Conditions
- To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB
- Registration Number
- NCT02036177
- Lead Sponsor
- Ocon Medical Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 366
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety issues 24 months Perforations, expulsions, mal-position etc
Patient experience 24 months Recording of menstrual cramping, pain and bleeding irregularities during the trial period
Discontinuation rate 24 months Pregnancy rate 24 months
- Secondary Outcome Measures
Name Time Method Physician opinion 24 months Ease of use in insertion and removal
Trial Locations
- Locations (1)
Spitalul Clinic "Nicolae Malaxa", Sectia Obstetri-ca-Ginecologie
🇷🇴Bucharest, Romania
Spitalul Clinic "Nicolae Malaxa", Sectia Obstetri-ca-Ginecologie🇷🇴Bucharest, Romania