Clinical trial NCT02036203: A Study on the Safety and Efficacy of the SCu300A IUB Compared to the TCu380 Copper IUD
Official title: A Prospective, Randomized, Single Blind, Two Arms Controlled Study of the Safety and Efficacy of the SCu300A IUB™ Spherical Copper Intrauterine Ball in Comparison to TCu 380 IUD Intra-uterine Contraceptive Device
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Reversible Prevention of Pregnancy
Lead sponsor: Ocon Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to evaluate the safety and efficacy of the IUB SCu300A spherical copper IUD compared to the standard T shaped copper IUD, the TCu380.

Participants will be followed for one year and quality of life measurements will be measured during this period as well.


Eligibility criteria: 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(major)

* 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 post abortal endometritis in the past 3 month
* Mucopurulent cervicitis
* Endometrial thickness more than 12 mm on insertion date
* Known 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

Primary outcomes:
measure: Perforation rate
timeFrame: During device insertion
measure: Device expulsion
timeFrame: 12 months
measure: Efficacy in preventing pregnancy
timeFrame: 12 months
measure: Device malposition
timeFrame: 12 months
Secondary outcomes:
measure: Menorrhagia and dysmenorrhea rates
timeFrame: 12 months
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Women's Health Center
Study officials:
References: