Clinical trial NCT02036177: Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB
Keywords: IUB
Lead sponsor: Ocon Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-14
Enrollment: 366
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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
* Distortions of the uterine cavity by uterine fibroids or known anatomical abnormalities
* Known intolerance or allergy to nitinol or copper and/or copper IUDs - Wilson's disease.
* Medication that may interfere with the subject's ability to complete the protocol
* Use of injectable contraception in the previous year
* Any other significant disease or condition that could interfere with the subject's ability to complete the protocol
* A history of alcohol or drug abuse
* Known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
* Pregnancy or pregnancy planned during the year
* Enrollment (less than 30 days after completing another study) in or planned to be enrolled in another study

Primary outcomes:
measure: Pregnancy rate
timeFrame: 24 months
measure: Safety issues
timeFrame: 24 months
measure: Discontinuation rate
timeFrame: 24 months
measure: Patient experience
timeFrame: 24 months
Secondary outcomes:
measure: Physician opinion
timeFrame: 24 months
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
city: Bucharest
country: Romania
facility: Spitalul Clinic "Nicolae Malaxa", Sectia Obstetri-ca-Ginecologie
Study officials:
References: