Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD

NCT02036177 | Completed Phase 4

• 1 other identifier: AOS-C2000
• Study Type: interventional
• Target: 366
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Keywords

IUB

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Physician opinion

  24 months

Study Arms (2)

SCu300A IUB

EXPERIMENTAL

Device: SCu300A IUB intrauterine device

T380A copper IUD

ACTIVE COMPARATOR

Device: T380A IUD

Interventions

SCu300A IUB intrauterine device DEVICE

Spherical copper IUD

SCu300A IUB

T380A IUD DEVICE

T-shaped copper IUD

T380A copper IUD

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult females aged 18-45
• Free and willing to fully comply with treatment process
• Healthy women seeking LARC
• Married or in a steady relationship (at least 1 year)
• Blood hemoglobin \>11.5gr/dL
• Signed informed consent form
• If took COCP at least had one cycle after use of OC

You may not qualify if:

• Use IUB/IUD as an emergency contraception
• A previously placed IUD that has not been removed
• Pregnancy or suspicion of pregnancy
• Immediately post-abortion or post-partum - unless had at least one free cycle
• Use of other contraception method (condom for either male or female, oral contraceptives, diaphragms, spermicides, hormonal patches, injections or ring, cervical cap)
• History of pelvic inflammatory disease, recent or remote.
• Postpartum endometritis or postabortal endometritis in the past 3 month
• Mucupurulent cervicitis
• Endometrial thickness more than 12 mm on insertion date
• Known anemia (except thalassemia, sickle cell, chronic anemia)
• Severe Mennorrhagia or severe Dysmenorrhea
• History of previous IUD complications
• Dysfunctional uterine bleeding
• Undiagnosed uterine bleeding
• Malignancy or suspected malignant disease of female inner or outer genitalia

Sponsors & Collaborators

• Ocon Medical Ltd.: lead

Study Sites (2)

Unknown Facility

Sofia, Bulgaria

Location

Spitalul Clinic "Nicolae Malaxa", Sectia Obstetri-ca-Ginecologie

Bucharest, Romania

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 14, 2014
• Study Start: June 12, 2014
• Primary Completion: July 15, 2017
• Study Completion: July 15, 2017
• Last Updated: July 6, 2018

Record last verified: 2018-07

Locations

RO (1); BU (1)