Trial Outcomes & Findings for Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs (NCT NCT00461253)
NCT ID: NCT00461253
Last Updated: 2016-01-25
Results Overview
Breast cancer (invasive carcinoma or carcinoma in situ) in women aged \<50 years at diagnosis. Cases were excluded if they had died before study start or had a history of malignancy.
Recruitment status
COMPLETED
Target enrollment
25565 participants
Primary outcome timeframe
retrospective, January 2000 to December 2007
Results posted on
2016-01-25
Participant Flow
Participant milestones
| Measure |
Cases
Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged \<50 years at diagnosis.
|
Controls
Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
|
|---|---|---|
|
Overall Study
STARTED
|
10093
|
40250
|
|
Overall Study
COMPLETED
|
5113
|
20452
|
|
Overall Study
NOT COMPLETED
|
4980
|
19798
|
Reasons for withdrawal
| Measure |
Cases
Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged \<50 years at diagnosis.
|
Controls
Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
|
|---|---|---|
|
Overall Study
Death
|
985
|
0
|
|
Overall Study
Protocol Violation
|
613
|
236
|
|
Overall Study
no response
|
2609
|
11789
|
|
Overall Study
administrative
|
773
|
7773
|
Baseline Characteristics
Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs
Baseline characteristics by cohort
| Measure |
Cases
n=5113 Participants
Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged \<50 years at diagnosis.
|
Controls
n=20452 Participants
Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
|
Total
n=25565 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
44.3 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Gender
Female
|
5,113 participants
n=5 Participants
|
20,452 participants
n=7 Participants
|
25565 participants
n=5 Participants
|
|
Gender
Male
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1815 participants
n=5 Participants
|
7260 participants
n=7 Participants
|
9075 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
3298 participants
n=5 Participants
|
13192 participants
n=7 Participants
|
16490 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: retrospective, January 2000 to December 2007Population: Frequency of breast cancer (in situ and invasive) in LNG-IUD users and Cu-IUD users
Breast cancer (invasive carcinoma or carcinoma in situ) in women aged \<50 years at diagnosis. Cases were excluded if they had died before study start or had a history of malignancy.
Outcome measures
| Measure |
LNG IUD
n=5346 Participants
Women who currently or ever used a LNG IUDs (Mirena) at time of breast cancer diagnosis
|
Cu-IUD
n=5428 Participants
Women who currently or ever used a copper IUDs at time of breast cancer diagnosis
|
|---|---|---|
|
Breast Cancer Risk
|
1076 participants
|
1068 participants
|
Adverse Events
LNG IUD
Serious events: 1085 serious events
Other events: 0 other events
Deaths: 0 deaths
Cu-IUD
Serious events: 1130 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LNG IUD
n=5346 participants at risk
Users of LNG IUDs (Mirena)
|
Cu-IUD
n=5428 participants at risk
Users of copper IUDs
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
20.3%
1085/5346 • Number of events 1085 • Retrospective population based case-control study identifying breast cancer cases in the between January 2000 and December 2007 in women younger than 50 years of age at time of diagnosis.
|
20.8%
1130/5428 • Number of events 1130 • Retrospective population based case-control study identifying breast cancer cases in the between January 2000 and December 2007 in women younger than 50 years of age at time of diagnosis.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jürgen Dinger
Center for Epidemiology and Health Research, Germany
Phone: 0049 (0) 30 945 101 20
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place