This trial is active, not recruiting.

Condition prevention of pregnancy
Treatments scu300a iub intrauterine device, t380a iud
Phase phase 2/phase 3
Sponsor Ocon Medical Ltd.
Start date May 2014
End date January 2016
Trial size 363 participants
Trial identifier NCT02036177, AOS-2000-04


The 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:

Comparison of objective parameters - Pregnancy rate, perforation, expulsion and malposition rates, changes in the endometrial thickness, rate of complications such as infection and anemia and discontinuation rates after 1 year.

Comparison of Subjective parameters - pain during insertion, menstrual characteristics and pain, bleeding in correlation to the bleeding pattern prior to insertion.

Physician opinion: ease of use in insertion and removal. Subject satisfaction.

It is expected that subjects using the copper IUB will demonstrate less safety events, equal effectiveness and equal or improved menstrual bleeding and pain related profiles compared with users of the T shaped copper IUD.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
scu300a iub intrauterine device
Spherical copper IUD
(Active Comparator)
t380a iud
T-shaped copper IUD

Primary Outcomes

Number of uterine perforations during insertion
time frame: At insertion visit
Expulsion and malposition rates
time frame: 12 months
Efficacy in preventing pregnancy
time frame: 12 months

Secondary Outcomes

Dysmenorrhea and menorrhagia severity
time frame: 12 months

Eligibility Criteria

Female participants from 25 years up to 42 years old.

Inclusion criteria: - Adult females aged 25-42 - 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% - 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 - 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) - 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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Ocon Medical Ltd..