A Study to Evaluate the Safety and Initial Efficacy of a Novel Intrauterine Device

NCT01590563 | Completed Results

• 1 other identifier: AOS-C1000-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (2)

• Rates of Uterine Perforation

  Uterine perforation is an established risk of IUD deployment which may cause certain health hazards. It is anticipated that the IUB(tm), through its form and deployment pattern, will reduce this risk.

  During installation

• Efficacy in Preventing Pregnancy

  Prevention of pregnancy will be measured. Pregnancy rates are expected to be comparable to current IUDs.

  12 months

Secondary Outcomes (1)

• Occurrence of Malposition, Expulsion.

  12 months

Study Arms (1)

SCu300A IUB

EXPERIMENTAL

Insertion of a spherical IUD (intrauterine device) with one year follow-up

Device: IUD

Interventions

IUD DEVICE

Insertion of a spherical IUD, one year follow-up

Also known as: SCu300A IUB(tm)

SCu300A IUB

Eligibility Criteria

• Age: 25 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ocon Medical Ltd.: lead

Study Sites (1)

Synexus Hungary Limited

Budapest, 1036, Hungary

Location

Related Publications (1)

• Baram I, Weinstein A, Trussell J. The IUB, a newly invented IUD: a brief report. Contraception. 2014 Feb;89(2):139-41. doi: 10.1016/j.contraception.2013.10.017. Epub 2013 Nov 7.

  PMID: 24309220 DERIVED

Results Point of Contact

• Title: Dr. Beata Szoczei, MD
• Organization: Synexus Hungary

+36 1 436 7330

Study Officials

• Beata Szoczei, MD

  Synexus Hungary Kft.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VP Clinical

Model Details: Intrauterine device

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: May 3, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 14, 2020
• Results First Posted: November 9, 2015

Record last verified: 2020-09

Locations

HU (1)