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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Szőczei Beáta, MD, Synexus
ClinicalTrials.gov Identifier:
NCT01590563
First received: April 20, 2012
Last updated: October 12, 2015
Last verified: October 2015
Results First Received: November 5, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Contraception.
Intervention: Device: IUD

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
SCu300A IUB Insertion of a spherical IUD (intrauterine device) with one year follow-up

Participant Flow:   Overall Study
    SCu300A IUB  
STARTED     15  
COMPLETED     14  
NOT COMPLETED     1  
simple uterine hyperplasia - not related                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
SCu300A IUB Insertion of a spherical IUD (intrauterine device) with one year follow-up

Baseline Measures
    SCu300A IUB  
Number of Participants  
[units: participants]
  15  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  33.9  (4.8)  
Gender, Customized  
[units: participants]
  15  
Region of Enrollment  
[units: participants]
 
Hungary     15  
Prior Contraception Use  
[units: participants]
 
Yes     8  
    7  



  Outcome Measures
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1.  Primary:   Rates of Uterine Perforation   [ Time Frame: During installation ]

2.  Primary:   Efficacy in Preventing Pregnancy   [ Time Frame: 12 months ]

3.  Secondary:   Occurrence of Malposition, Expulsion.   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Beata Szoczei, MD
Organization: Synexus Hungary
phone: +36 1 436 7330


No publications provided by Ocon Medical Ltd.

Publications automatically indexed to this study:

Responsible Party: Szőczei Beáta, MD, Synexus
ClinicalTrials.gov Identifier: NCT01590563     History of Changes
Other Study ID Numbers: AOS-C1000-02
Study First Received: April 20, 2012
Results First Received: November 5, 2013
Last Updated: October 12, 2015
Health Authority: Hungary: Scientific and Medical Research Council Ethics Committee