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

Tracking Information
First Submitted Date ICMJE	April 20, 2012
First Posted Date ICMJE	May 3, 2012
Results First Submitted Date	November 5, 2013
Results First Posted Date	November 9, 2015
Last Update Posted Date	November 9, 2015
Study Start Date ICMJE	April 2012
Actual Primary Completion Date	July 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 12, 2015)	Rates of Uterine Perforation [ Time Frame: During installation ]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.; Efficacy in Preventing Pregnancy [ Time Frame: 12 months ]Prevention of pregnancy will be measured. Pregnancy rates are expected to be comparable to current IUDs.
Original Primary Outcome Measures ICMJE; (submitted: May 2, 2012)	Comparable or reduced rates of uterine perforation [ Time Frame: During installation ]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.; Efficacy in Preventing Pregnancy [ Time Frame: 12 months ]Prevention of pregnancy will be measured. Pregnancy rates are expected to be comparable to current IUDs.
Change History	Complete list of historical versions of study NCT01590563 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 12, 2015)	Occurrence of Malposition, Expulsion. [ Time Frame: 12 months ]; Expulsion and malposition are established risks involved with IUD use. Occurrence of these risks may drastically reduce effectiveness. It is expected that the IUB(tm) form will reduce these risks.
Original Secondary Outcome Measures ICMJE; (submitted: May 2, 2012)	Comparable or reduced occurence of malposition, expulsion, change in bleeding pattern and pain. [ Time Frame: 12 months ]; Expulsion and malposition are established risks involved with IUD use. Occurance of these risks may drastically reduce effectiveness. Change in bleeding patterns and pain incurred by the patient are also known side effects which affect patient quality of life and may result in IUD removal. It is expected that the IUB(tm) form will reduce these risks and side effects.
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study to Evaluate the Safety and Initial Efficacy of a Novel Intrauterine Device
Official Title ICMJE	A Study to Evaluate the Safety and Initial Efficacy of a Spherical Copper Intrauterine Contraceptive Device the IUB(tm)
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.
Detailed Description	A copper IUD (intrauterine device or coil) is a type of intrauterine contraceptive device. Most IUDs have a plastic T-shaped frame which is wrapped in copper wire and sleeves. The device has to be fitted inside and removed from the uterine cavity by a doctor or qualified medical practitioner. It remains in place the entire time pregnancy is not desired. The IUD is a long acting reversible contraceptive, with different IUDs intended to last for different lengths of time, usually between 3 and 10 years. The length of time that the device lasts depends mainly on the amount of exposed copper, which is indicated, in square millimeters, by a number in the name of each device (i.e., the Paragard T-380A has 380 square millimeters of exposed copper). The IUD is the world's most widely used method of reversible birth control, currently used by over 175 million women. The mechanism of IUDs is not well understood. It is known however that the presence of a device in the uterus prompts the release of leukocytes and prostaglandins by the endometrium. These substances are hostile to both sperm and eggs; the presence of copper increases the spermicidal effect. The general medical consensus is that spermicidal and ovicidal mechanisms are the only way in which IUDs work. Some physicians and medical texts have suggested they may have a secondary effect of interfering with the development of pre-implanted embryos; this secondary effect is considered more plausible when the IUD is used as emergency contraception. Second-generation copper-T IUDs have failure rates of less than 1% per year, and cumulative 10-year failure rates of 2-6%. A copper IUD may also be used as emergency contraception. If an IUD is inserted within five days of unprotected intercourse, a woman's chance of pregnancy is reduced to that of ongoing IUD users. IUDs do not protect against STDs or PID. Made from a shape memory alloy of a specific size and shape, the SCu300A IUB™ is inserted through an insertion tube much like regular IUDs, however, when pushed out, in the uterus, it takes a spherical shape. An important feature includes its downwards curving opposite to the uterine fundus as it emerges out of the tube, minimizing the risk of perforation. The three dimensional shape's elasticity allows for better amenability to the uterus, nullifying the possibility of malposition and its final outer diameter reducing the probability of expulsion. Lacking rigid or protruding segments and being significantly smaller than other IUDs, the IUB™ is expected to reduce distortion and tissue irritation, possibly resulting in less bleeding, discomfort and pain, leading to lower discontinuation rates. A thread is attached to the IUB™ to allow easy removal. The trialed IUB™ will be copper-based (Cu surface area of 300mm2). This study aims to assess the IUB™'s safety and initial efficacy. Endpoints include the assessment of changes in discomfort, pain and menorrhea, changes in the endometrium discontinuation rates as well as user experience. These results will be used as regulatory evidence and will also help in reaffirming the assumption that the IUB™'s design contributes to lower complication and side effect rates.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Contraception.
Intervention ICMJE	Device: IUD; Insertion of a spherical IUD, one year follow-up; Other Name: SCu300A IUB(tm)
Study Arms	Experimental: SCu300A IUB; Insertion of a spherical IUD (intrauterine device) with one year follow-up; Intervention: Device: IUD
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 2, 2012)	15
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	July 2013
Actual Primary Completion Date	July 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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%.
Sex/Gender	Sexes Eligible for Study: Female
Ages	25 Years to 42 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Hungary
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01590563
Other Study ID Numbers ICMJE	AOS-C1000-02
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Szőczei Beáta, MD, Synexus
Study Sponsor ICMJE	Ocon Medical Ltd.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Beata Szoczei, MD Synexus Hungary Kft.
PRS Account	Ocon Medical Ltd.
Verification Date	October 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP