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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menorrhagia, Dysmenorrhea

Intervention: Mirena (Levonorgestrel IUS, BAY86-5028) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Number of participants with adverse drug reaction

Number of participants with adverse events

Secondary outcome:

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

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

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

Change from baseline in dysmenorrhea pain using Visual Analogue scale

Use of analgesic

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Many Locations, Japan; Recruiting
Additional Information

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Starting date: August 2015
Last updated: August 21, 2015

Page last updated: August 23, 2015

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