Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea

• Status: Completed
• Trial end date: 2019-12-12
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective in this study is collecting post-marketing information on the safety. Thus, it includes information under the routine clinical practice on adverse events (AEs) and adverse drug reactions (ADRs) including expulsion and abnormal bleeding that occur within the first 12 months Mirena insertion.

The secondary objective(s) in this study is/are collecting information on Mirena effectiveness, such as periodic blood loss and Quality of life (QOL), use of analgesic and dysmenorrhea pain as far as these are recorded under routine clinical practice.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Levonorgestrel

Criteria

Inclusion Criteria:

• Female patients diagnosed with HMB or/and dysmenorrhea.

• Patients for whom newly starting treatment with Mirena was made as per investigator's routine treatment practice

• Written informed consent

Exclusion Criteria:

• Patient whose purpose is only contraception