N/A
N=15
A Study to Evaluate the Safety and Initial Efficacy of a Novel Intrauterine Device
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT01590563 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Rates of Uterine Perforation — 0 Number of cases
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IUD (Device)
- Age
- Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Ocon Medical Ltd.
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Uterine Perforation |
— | — |
| PRIMARY Efficacy in Preventing Pregnancy |
— | — |
| SECONDARY Occurrence of Malposition, Expulsion. |
— | — |
Summary
Current intrauterine devices (IUD) pose such risks as uterine perforation during insertion, malposition and expulsion. The investigated device, the IUB(tm) SCu300A is an IUD which is inserted in a similar fashion into the uterus and takes a three dimensional spherical shape while curving away from the fundus. Apart for an anticipated reduction in the rate of stated complications, its smaller size and mallable characteristics are also expected to improve user experience. The clinical trial is intended to evaluate the safety and initial efficacy of this novel device.
Eligibility Criteria
Inclusion Criteria
- Adult female aged 25-42
- Free willing to fully comply with treatment process
- Healthy women
- Married or in a steady relationship. Blood hemoglobin >11.5gr%
- Signed informed consent form
Exclusion Criteria
- Pregnancy or suspicion of pregnancy
- Use of other contraception methods
- Abnormalities of the uterus resulting in distortion of the uterine cavity
- Acute current or past history of pelvic inflammatory disease, or current behavior suggesting a high risk for pelvic inflammatory disease
- Postpartum endometritis or postabortal endometritis in the past 3 months
- Known or suspected uterine or cervical malignancy
- Genital bleeding of unknown etiology
- Mucopurulent cervicitis
- Wilson's disease
- Allergy to any component of IUB™
- A previously placed IUD that has not been removed
- Known intolerance or allergy to copper and/or copper IUDs
- Medication that may interfere with the subject's ability to complete the protocol
- 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
- Planned pregnancy during the follow-up period
- Participation in another clinical trial
- Anemia of any kind or blood hemoglobin lower than 11.5gr%.
Data sourced from ClinicalTrials.gov (NCT01590563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.