Status: Finalised First registered on: 04/02/2020
Last updated on: 11/11/2020
1. Study identification
EU PAS Register NumberEUPAS33461
Official titleStudy on the association of uterine perforation and intrauterine device (IUD) expulsion with breastfeeding status at the time of IUD insertion and postpartum timing of IUD insertion in electronic medical record databases. A postmarketing requirement for Mirena
Study title acronymAPEX IUD
Study typeObservational study
Brief description of the studyThis study is an US postmarketing requirement that investigates the outcomes of uterine perforation and intrauterine device (IUD) expulsion in association with breastfeeding, postpartum exposures and type of IUD. The study aims to quantify the risk of uterine perforation and IUD expulsion in relation to the breastfeeding status and postpartum time (≤ 6 , > 6 ≤ 14, > 14, ≤ 52 or > 52 weeks postpartum, including women without a recorded delivery within the past 52 weeks) at the time of IUD insertion This study will also assess the risk of both perforation and expulsion by type of IUD. The effect of IUD types (LNG-releasing vs. copper) on the association between perforation/ expulsion and breastfeeding status/ postpartum status, as well as the effect of breastfeeding status on the association between perforation and/or expulsion and postpartum status are also investigated.
Was this study requested by a regulator?Yes: United States
Is the study required by a Risk Management Plan (RMP)? Non-EU RMP only
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableCT.gov: NCT03754556 Bayer No.: 19682
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Dr
Last name Bayer AG
First name Bayer Clinical Trials
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4
Kaiser Permanente Northern California, Oakland, USA
Kaiser Permanente Southern California, Pasadena, USA
Kaiser Permanente Washington, Seattle, USA
Regenstrief Institute, Indianapolis, USA
Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed29/06/201629/06/2016
Start date of data collection01/12/201803/12/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report30/04/202003/03/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Bayer AG
First name Bayer Clinical Trials
Address line 1Muellerstrasse 178
Address line 2 
Address line 3 
CityBerlin 
Postcode 
CountryGermany
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address Clinical-Trials-Contact@bayer.com
Public Enquiries
Title Dr 
Last name Bayer AG 
First name Bayer Clinical Trials 
Address line 1Muellerstrasse 178 
Address line 2 
Address line 3 
CityBerlin 
Postcode 
CountryGermany 
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address Clinical-Trials-Contact@bayer.com 
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