A Study to Evaluate the Safety and Initial Efficacy of a Novel Intrauterine Device
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ClinicalTrials.gov Identifier: NCT01590563 |
Recruitment Status
:
Completed
First Posted
: May 3, 2012
Results First Posted
: November 9, 2015
Last Update Posted
: November 9, 2015
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Tracking Information | ||||
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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 |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT01590563 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE |
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.
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Contraception. | |||
Intervention ICMJE | Device: IUD
Insertion of a spherical IUD, one year follow-up
Other Name: SCu300A IUB(tm) |
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Study Arms | Experimental: SCu300A IUB
Insertion of a spherical IUD (intrauterine device) with one year follow-up
Intervention: Device: IUD |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |