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The novel SCu300A IUBâ„¢ (hereafter IUBâ„¢) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCu300A IUB | Experimental |
| |
| T380A copper IUD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCu300A IUB intrauterine device | Device | Spherical copper IUD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | 24 months | |
| Safety issues | Perforations, expulsions, mal-position etc | 24 months |
| Discontinuation rate | 24 months | |
| Patient experience | Recording of menstrual cramping, pain and bleeding irregularities during the trial period | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physician opinion | Ease of use in insertion and removal | 24 months |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sofia | Bulgaria | |||||
| Spitalul Clinic "Nicolae Malaxa", Sectia Obstetri-ca-Ginecologie |
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| T380A IUD |
| Device |
T-shaped copper IUD |
|
| Bucharest |
| Romania |