European Active Surveillance Study of LCS12

NCT02146950 | Active Not Recruiting DMC

• 3 other identifiers: ZEG2013_1016470EUPAS6476
• Study Type: observational
• Target: 97,265
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to investigate whether LCS12 is associated with an increased risk of unintended pregnancy compared to Mirena and to copper IUDs. The objective is to assess among new users the risks of certain events (e.g. contraceptive failure rate, ectopic pregnancy, uterine perforation, and PID) associated with the use of LCS12 compared with the established hormonal IUD Mirena, and compared with established copper IUDs during standard clinical practice. In addition, drug utilization patterns will be described.

Conditions

Contraception

Keywords

LCS-12; Intrauterine Device (IUD); Intrauterine System (IUS); Levonorgestrel; Pearl Index; Hormonal Contraception

Outcome Measures

Primary Outcomes (1)

• Contraceptive failure (LCS12 vs. Mirena and copper IUDs)

  within 3 years

Secondary Outcomes (4)

• Pelvic inflammatory disease (PID)

  within 3 - 5 years

• Ectopic pregnancy

  within 3 - 5 years

• Uterine perforations

  within 3 - 5 years

• Contraceptive failure (Kyleena vs. Mirena and copper IUDs)

  within 5 years

Study Arms (5)

LCS12

New users of LCS12

Mirena

New users of Mirena

Copper IUD

New users of copper IUDs

Kyleena

New users of Kyleena

Other hormonal IUD (OHIUD)

New users of other hormonal IUDs (e.g. Levosert, Fibroplant)

Eligibility Criteria

• Age: Up to 39 Years
• Gender Eligibility Details: Only women are eligible for enrolment
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women using an intrauterine system/device (hormonal IUS or copper IUD)

You may qualify if:

• Women aged below 40 years who have a new IUD inserted (LCS12, Kyleena, Mirena, copper IUD, or any other hormonal IUD)
• Women who are willing to participate in the active surveillance

You may not qualify if:

• Women aged 40 or older at insertion day
• Women who are currently enrolled in an interventional trial on IUD use can not participate

Sponsors & Collaborators

• Center for Epidemiology and Health Research, Germany: lead
• Bayer: collaborator

Study Sites (1)

Center for Epidemiology and Health Research Berlin

Berlin, 10115, Germany

Location

Related Publications (7)

• Boehnke T, Eggebrecht L, Rizzo M, Klinghardt M, Heinemann K. Polished but pointless? Assessing the potential of gold and silver-alloy IUDs versus copper-only devices in a large multinational cohort (EURAS-LCS12). Eur J Contracept Reprod Health Care. 2026 Jan 26:1-5. doi: 10.1080/13625187.2026.2616357. Online ahead of print.

  PMID: 41587081 RESULT

• Eggebrecht L, Rizzo M, Klinghardt M, Bohnke T, Barnett C, Heinemann K. Real-world use of antispasmodic drugs during IUD insertion - insights from the large observational study EURAS-LCS12. Eur J Contracept Reprod Health Care. 2025 Jun;30(3):149-152. doi: 10.1080/13625187.2025.2480086. Epub 2025 Apr 4.

  PMID: 40183207 RESULT

• Klinghardt M, Rizzo M, Boehnke T, Barnett C, Heinemann K, Eggebrecht L. Use of oral medications prior to IUD insertion - Trends and associations of patient characteristics in a large observational study in Europe (EURAS-LCS12). Eur J Obstet Gynecol Reprod Biol. 2025 Dec;315:114789. doi: 10.1016/j.ejogrb.2025.114789. Epub 2025 Oct 22.

  PMID: 41151245 RESULT

• Eggebrecht L, Rizzo M, Klinghardt M, Boehnke T, Barnett C, Heinemann K. Medical habit or necessity? Investigating misoprostol use for IUD insertion in Europe. Eur J Contracept Reprod Health Care. 2026 Feb 11:1-7. doi: 10.1080/13625187.2026.2625138. Online ahead of print.

  PMID: 41672075 RESULT

• Boehnke T, Eggebrecht L, Viet M, Heinemann K, Bauerfeind A. How did regional lockdowns during the COVID-19 pandemic affect recruitment into a large multinational cohort study of intrauterine device users? Contraception. 2023 Jul;123:110003. doi: 10.1016/j.contraception.2023.110003. Epub 2023 Mar 12.

  PMID: 36918064 RESULT

• Eggebrecht L, Bauerfeind A, Boehnke T, Rizzo M, Hagemann C, Lange J, Viet M, Pauls K, von Stockum S, Klinghardt M, Heinemann K. Population characteristics of intrauterine device users in real-world clinical practice across Europe - insights from the EURAS-LCS12 study. Contracept Reprod Med. 2025 Mar 14;10(1):20. doi: 10.1186/s40834-025-00353-8.

  PMID: 40087799 RESULT

• Boehnke T, Bauerfeind A, Eggebrecht L, Cellier C, Lange JA, Heinemann K, Madden T. Does the shape of the copper intrauterine device play a role in expulsion? Results from the ongoing European Active Surveillance Study on LCS12. Contraception. 2024 Dec;140:110444. doi: 10.1016/j.contraception.2024.110444. Epub 2024 Mar 27.

  PMID: 38552821 RESULT

Related Links

• Boehnke T, Bauerfeind A, Hagemann C, Lange JA, Heinemann K, Intrauterine device prescribing patterns and types in Europe - a cross-sectional analysis of the European Active Surveillance LCS12 Study. European Gynecology \& Obstetrics

Study Officials

• Klaas Heinemann, PhD, MD, MSc, MBA

  Center for Epidemiology and Health Research Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 26, 2014
• Study Start: June 17, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

DE (1)