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Mirena Insertion at Two-weeks Postpartum
NCT02121067Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2014
- Primary completion
- Jun 2016
- Countries
- 1
- Sponsor
- University of North Carolina at Chapel Hill
- Modality
- Small Molecules
- Drugs
- avatrombopag
- Conditions
- contraception
01
Overview
Phase 4, open-label, single-arm trial of avatrombopag in contraception, sponsored by University of North Carolina at Chapel Hill. Primary endpoints: Number of Participants Who Would Recommend the LNG-IUS to a Friend and Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion. Started Sep 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
LNG-IUS placed at 2 weeks postpartum
Mirena insertion at 14-20 days postpartum
03
Who it enrols
Postpartum women (18-45) desiring LNG-IUS contraception, delivering >32 weeks, with no active infection, liver disease, or breast cancer history.
04
Endpoints
Primary
Number of Participants Who Would Recommend the LNG-IUS to a Friend
Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion
Secondary
Number of Participants With Expulsion (Complete or Partial) of LNG-IUS
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