Trial Outcomes & Findings for European Active Surveillance Study for Intrauterine Devices (NCT NCT00461175)

NCT ID: NCT00461175

Last Updated: 2015-07-17

Results Overview

Uterine perforation is a potentially serious complication of intrauterine device (IUD) use. The absolute risk of uterine perforation associated with the LNG IUS in routine medical practice has not hitherto been well defined. It is also unknown whether the perforation rate is higher with this IUD than with copper IUDs.

• Recruitment status: COMPLETED
• Target enrollment: 63194 participants
• Primary outcome timeframe: 12 months after insertion
• Results posted on: 2015-07-17

Participant Flow

Overall, 63,194 patients were recruited for the EURAS-IUD study, and 1,746 patients were excluded due to protocol violations. Of these, information on the IUD inserted at baseline is missing for 859 women. Therefore, 859 recruited patients could not be assigned to one of the cohorts and are not counted in the table displaying the participant flow.

Participant milestones

Measure	LNG IUS New users of Mirena® IUS	Copper IUD New users of Copper IUD
Overall Study STARTED	43600	18735
Overall Study COMPLETED	43078	18370
Overall Study NOT COMPLETED	522	365

Reasons for withdrawal

Measure	LNG IUS New users of Mirena® IUS	Copper IUD New users of Copper IUD
Overall Study Protocol Violation	522	365

Baseline Characteristics

European Active Surveillance Study for Intrauterine Devices

Baseline characteristics by cohort

Measure	LNG IUS n=43078 Participants New users of Mirena® IUS	Copper IUD n=18370 Participants New users of Copper IUD	Total n=61448 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	43069 Participants n=93 Participants	18370 Participants n=4 Participants	61439 Participants n=27 Participants
Age, Categorical >=65 years	9 Participants n=93 Participants	0 Participants n=4 Participants	9 Participants n=27 Participants
Age, Continuous	37.37 years STANDARD_DEVIATION 7.54 • n=93 Participants	33.33 years STANDARD_DEVIATION 7.64 • n=4 Participants	36.2 years STANDARD_DEVIATION 7.8 • n=27 Participants
Sex: Female, Male Female	43078 Participants n=93 Participants	18370 Participants n=4 Participants	61448 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Germany	16981 participants n=93 Participants	6023 participants n=4 Participants	23004 participants n=27 Participants
Region of Enrollment Austria	6303 participants n=93 Participants	1947 participants n=4 Participants	8250 participants n=27 Participants
Region of Enrollment Finland	2280 participants n=93 Participants	585 participants n=4 Participants	2865 participants n=27 Participants
Region of Enrollment United Kingdom	14190 participants n=93 Participants	6784 participants n=4 Participants	20974 participants n=27 Participants
Region of Enrollment Sweden	2693 participants n=93 Participants	2018 participants n=4 Participants	4711 participants n=27 Participants
Region of Enrollment Poland	631 participants n=93 Participants	1013 participants n=4 Participants	1644 participants n=27 Participants

PRIMARY outcome

Timeframe: 12 months after insertion

Population: Intention-to-treat (ITT) population. "Number of Participants" referring to the initially inserted IUS/IUD or the initial IUD insertion attempt.

Uterine perforation is a potentially serious complication of intrauterine device (IUD) use. The absolute risk of uterine perforation associated with the LNG IUS in routine medical practice has not hitherto been well defined. It is also unknown whether the perforation rate is higher with this IUD than with copper IUDs.

Outcome measures

Measure	LNG IUS n=43078 Participants New users of Mirena® IUS	Copper IUD n=18370 Participants New users of Copper IUD
Uterine Perforation Rate	61 participants	20 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 12 months

Intrauterine contraceptive methods have low Pearl Indices. Nevertheless, there is a lack of comparative data between LNG IUS users and copper IUD users. Women with unintended pregnancies were explicitly aked whether the pregnancy occured despite IUD use. The 29 pregnancies that occured after unrecognized IUD expulsion were considered to have resulted from a failure of the contraceptive method and were therefore included in the analysis.

Outcome measures

Measure	LNG IUS n=43078 Participants New users of Mirena® IUS	Copper IUD n=18370 Participants New users of Copper IUD
Contraceptive Failure	26 participants	92 participants

Adverse Events

LNG IUS

Serious events: 21 serious events

Other events: 0 other events

Deaths: 0 deaths

Copper IUD

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	LNG IUS n=43078 participants at risk New users of Mirena® IUS	Copper IUD n=18370 participants at risk New users of Copper IUD
Cardiac disorders Venous thromboembolic event	0.02% 9/43078 • Information on adverse events was collected over a time period of 12 months. All participants and health care providers were asked for adverse events at the follow-up 12 months after baseline.	0.03% 5/18370 • Information on adverse events was collected over a time period of 12 months. All participants and health care providers were asked for adverse events at the follow-up 12 months after baseline.
Cardiac disorders Cerebrovascular Events	0.02% 9/43078 • Information on adverse events was collected over a time period of 12 months. All participants and health care providers were asked for adverse events at the follow-up 12 months after baseline.	0.01% 1/18370 • Information on adverse events was collected over a time period of 12 months. All participants and health care providers were asked for adverse events at the follow-up 12 months after baseline.
Cardiac disorders Myocardial infarction	0.00% 2/43078 • Information on adverse events was collected over a time period of 12 months. All participants and health care providers were asked for adverse events at the follow-up 12 months after baseline.	0.01% 1/18370 • Information on adverse events was collected over a time period of 12 months. All participants and health care providers were asked for adverse events at the follow-up 12 months after baseline.
Cardiac disorders Other arterial thromboembolic event	0.00% 1/43078 • Information on adverse events was collected over a time period of 12 months. All participants and health care providers were asked for adverse events at the follow-up 12 months after baseline.	0.00% 0/18370 • Information on adverse events was collected over a time period of 12 months. All participants and health care providers were asked for adverse events at the follow-up 12 months after baseline.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Klaas Heinemann

Center for Epidemiology and Health Research, Germany

Phone: 0049 (0) 30 945 101 20

Email: k.heinemann@zeg-berlin.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place