NCT02475356

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

Special Drug Use Investigation of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 601 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

This local, non-interventional, multicenter, single-cohort study using primary data includes patients treated with Mirena for Heavy menstrual bleeding(HMB) and/or dysmenorrhea (contraception is not included). A total of 600 patients (valid for safety analysis) is planned to be enrolled in two years. No formal sample size estimation was conducted, it was determined based on feasibility. Target population is patients with HMB and/or dysmenorrhea diagnosis. The treatment should be performed based on the product label in Japan. The standard observation period will last for 12 months from starting Mirena treatment.

Conditions

• Menorrhagia, Dysmenorrhea

Interventions

Type	Name	Description
DRUG	Levonorgestrel IUS (Mirena, BAY86-5028)	The treatment of Mirena should comply with the local product information.

Timeline

• Start date: 2015-08-04
• Primary completion: 2019-01-18
• Completion: 2019-12-12
• First posted: 2015-06-18
• Last updated: 2021-01-28

Locations

1 site across 1 country: Japan