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

NCT02475356 | Completed

• 1 other identifier: 18252
• Study Type: observational
• Target: 601
• Locations: 1 country
• Sites: 1

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.

Conditions

Menorrhagia, Dysmenorrhea

Keywords

Mirena; Heavy Menstrual Bleeding; Dysmenorrhea; Japan; Post-marketing surveillance

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse drug reaction

  Up to 12 months

• Number of participants with treatment-emergent adverse events (TEAEs)

  Up to 12 months

Secondary Outcomes (5)

• Change from baseline in bleeding characterized by Pictorial Blood loss Assessment Chart (PBAC) score to 12 months

  Baseline and 12 months

• Change from baseline in monthly bleeding intensities (the number of spotting and/or bleeding days) to 12 months

  Baseline and 12 months

• Change from baseline in Quality of Life parameters assessed using MMAS or MDQ score after 3 and 12 months

  Baseline and 3 months, Baseline and 12 months

• Change from baseline in dysmenorrhea pain using Visual Analogue scale

  Baseline and 1 month, Baseline and 3 months, Baseline and 6 months, Baseline and 12 months

• Change from baseline in use of analgesics after Mirena insertion

  Baseline and 12 months

Study Arms (1)

Mirena

Mirena treatment group

Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Interventions

Levonorgestrel IUS (Mirena, BAY86-5028) DRUG

The treatment of Mirena should comply with the local product information.

Mirena

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patient whose purpose is only contraception

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

Related Publications (1)

• 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.

  PMID: 35705788 DERIVED

Related Links

• Click here to find results for studies related to Bayer products.

MeSH Terms

Conditions

Menorrhagia; Dysmenorrhea

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 18, 2015
• Study Start: August 4, 2015
• Primary Completion: January 18, 2019
• Study Completion: December 12, 2019
• Last Updated: January 28, 2021

Record last verified: 2020-12

Locations

JP (1)