Clinical trial NCT02475356: Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea
Official title: Special Drug Use Investigation of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menorrhagia, Dysmenorrhea
Keywords: Mirena
Heavy Menstrual Bleeding
Dysmenorrhea
Japan
Post-marketing surveillance
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-06-18
Enrollment: 601
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with Heavy menstrual bleeding (HMB) and/or dysmenorrhea in whom a decision to initiate treatment with Mirena has already been made will be enrolled in the study.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Number of participants with adverse drug reaction
timeFrame: Up to 12 months
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Change from baseline in bleeding characterized by Pictorial Blood loss Assessment Chart (PBAC) score to 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in monthly bleeding intensities (the number of spotting and/or bleeding days) to 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in Quality of Life parameters assessed using MMAS or MDQ score after 3 and 12 months
timeFrame: Baseline and 3 months, Baseline and 12 months
measure: Change from baseline in dysmenorrhea pain using Visual Analogue scale
timeFrame: Baseline and 1 month, Baseline and 3 months, Baseline and 6 months, Baseline and 12 months
measure: Change from baseline in use of analgesics after Mirena insertion
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Momoeda M, Akira S, Harada T, Kitawaki J, Maeda N, Ota I, Yoshihara K, Takahashi N. Quality of Life of Japanese Dysmenorrhea/Heavy Menstrual Bleeding Patients Treated with Levonorgestrel Intrauterine Delivery System in a Real-World Setting. Adv Ther. 2022 Aug;39(8):3616-3634. doi: 10.1007/s12325-022-02205-2. Epub 2022 Jun 16.