Reversible Prevention of Pregnancy Clinical Trial
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
| Verified date | July 2018 |
| Source | Ocon Medical Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | January 14, 2014 |
| Est. primary completion date | January 14, 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 25 Years to 42 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Women's Health Center | Netanya |
| Lead Sponsor | Collaborator |
|---|---|
| Ocon Medical Ltd. |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Perforation rate | Number of subjects with partial or complete perforation through the uterine wall | During device insertion | |
| Primary | Device expulsion | Number of subjects with partially or fully ejected devices | 12 months | |
| Primary | Efficacy in preventing pregnancy | Number of women who become pregnant during the trial period. | 12 months | |
| Primary | Device malposition | Number of subjects with observed device malposition within the uterine cavity | 12 months | |
| Secondary | Menorrhagia and dysmenorrhea rates | Recording of menstrual pain, cramps and irregular bleeding as reported by subjects. | 12 months |