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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01590563
Recruitment Status : Completed
First Posted : May 3, 2012
Results First Posted : November 9, 2015
Last Update Posted : November 9, 2015
Information provided by (Responsible Party):
Szőczei Beáta, MD, Synexus

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Contraception.
Intervention: Device: IUD

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
SCu300A IUB Insertion of a spherical IUD (intrauterine device) with one year follow-up

Participant Flow:   Overall Study
    SCu300A IUB
simple uterine hyperplasia - not related                1 

  Baseline Characteristics

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
SCu300A IUB Insertion of a spherical IUD (intrauterine device) with one year follow-up

Baseline Measures
   SCu300A IUB 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   15 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 33.9  (4.8) 
Gender, Customized 
[Units: Participants]
Region of Enrollment 
[Units: Participants]
Hungary   15 
Prior Contraception Use 
[Units: Participants]
Yes   8 
No   7 

  Outcome Measures

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

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

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Szőczei Beáta, MD, Synexus Identifier: NCT01590563     History of Changes
Other Study ID Numbers: AOS-C1000-02
First Submitted: April 20, 2012
First Posted: May 3, 2012
Results First Submitted: November 5, 2013
Results First Posted: November 9, 2015
Last Update Posted: November 9, 2015