N/A
N=50,343
Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00461253 ↗Enrolled (actual)
50,343
Serious AEs
20.6%
Results posted
Jan 2016
Primary outcome: Primary: Breast Cancer Risk — 1076; 1068 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Levonorgestrel-releasing IUD (Device); Copper IUD (Device)
- Age
- Pediatric, Adult
- Sex
- Female
- Sponsor
- Center for Epidemiology and Health Research, Germany
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breast Cancer Risk |
1076; 1068 | — |
Summary
The objective of this study is to determine the breast cancer risk of Mirena® users compared to copper intrauterine device (IUD) users in a community-based case-control study.
Eligibility Criteria
Inclusion Criteria
- cases: women with a breast cancer who are younger than 50 years of age at cancer diagnosis
- controls: women without a breast cancer diagnosis who are younger than 50 years at the time of the interview
Exclusion Criteria
- women who are not willing to participate
Data sourced from ClinicalTrials.gov (NCT00461253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.