Skip to main content
OpenTrials
Completed

NCT Number: NCT02036177

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.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SCu300A IUB intrauterine device

Device

Spherical copper IUD

T380A IUD

Device

T-shaped copper IUD

Primary outcomes

  1. Pregnancy rate

    Time frame: 24 months

  2. Safety issues

    Time frame: 24 months

    Perforations, expulsions, mal-position etc

  3. Discontinuation rate

    Time frame: 24 months

  4. Patient experience

    Time frame: 24 months

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

Secondary outcomes

  1. Physician opinion

    Time frame: 24 months

    Ease of use in insertion and removal

Sponsors and collaborators

Lead sponsor

Ocon Medical Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 14, 2014
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.