Mirena or Conventional Medical Treatment for Menorrhagia

NCT00864136 | Completed

• 3 other identifiers: 14697MA0701MA0901 - non-East Asia
• Study Type: observational
• Target: 647
• Locations: 8 countries
• Sites: 8

Brief Summary

The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Mirena in treatment of prolonged or heavy menstrual bleeding (Menorrhagia) under daily-life treatment conditions. It is planned to conduct the study in about 10 countries with a total of 1000 patients. In several countries, a comparator group will also be documented. For each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12 months will be documented by the treating physician on the case report form. Observations include the patient's demographic parameters (date of birth, height, weight, race and smoking habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline menstruation, result of insertion, concomitant medications and diseases as well as menorrhagia symptoms. Overall treatment success will be evaluated at the end of treatment including number of weeks until improvement and reduction of menstrual bleeding with respect to duration and severity, and patient's satisfaction.

Conditions

Menorrhagia

Outcome Measures

Primary Outcomes (1)

• Cumulative continuation rate stratified by history of previous treatment(s) for menorrhagia

  at 12 months

Secondary Outcomes (4)

• Bleeding pattern

  at 12 months

• Patient satisfaction at end of documentation

  at 12 months

• Impact of the therapy in terms of patient-derived health outcomes (validated patient questionnaire)

  at 12 months

• Adverse events collection

  at 12 months

Study Arms (3)

Group 1

Drug: Levonorgestrel (Mirena, BAY86-5028)

Group 2

Drug: Conventional medical treatment

Group 3

Drug: Conventional medical treatment

Interventions

Levonorgestrel (Mirena, BAY86-5028) DRUG

Women using Mirena for treatment of menorrhagia

Group 1

Conventional medical treatment DRUG

Women using combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug

Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with a diagnosis of idiopathic menorrhagia can be enrolled after decision for treatment has been made.

You may qualify if:

• Women between the ages of 18-45 (inclusive) not intending to get pregnant during the next year
• Women complaining of heavy menstrual bleeding over several consecutive cycles
• Women without structural or histological abnormality of the uterus, or with fibroids less than 3 cm in diameter which are causing no distortion of the uterine cavity (eligible for pharmaceutical treatment according to the NICE guideline 2007)
• Informed consent (where required by laws or regulations)

You may not qualify if:

• The contraindications and warnings of the respective Summary of Product Characteristics (Mirena, combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug, or anti-fibrinolytic agent) must be followed.
• Women taking hormone replacement therapy
• Women with symptoms such as intermenstrual or post-coital bleeding, unless an endometrial biopsy has been performed and pathology excluded
• Women with fibroids that are palpable abdominally or who have intra-cavity fibroids and/or whose uterine length as measured at ultrasound or hysteroscopy is greater than 12 cm (NICE guideline 2007)
• Women on anticoagulative therapy or other treatment (including e.g. Copper IUD use) known to cause menorrhagia

Sponsors & Collaborators

• Bayer: lead

Study Sites (8)

Unknown Facility

Many Locations, China

Location

Unknown Facility

Many Locations, Hong Kong

Location

Unknown Facility

Many Locations, Indonesia

Location

Unknown Facility

Many Locations, Malaysia

Location

Unknown Facility

Many Locations, Pakistan

Location

Unknown Facility

Many Locations, South Korea

Location

Unknown Facility

Many Locations, Taiwan

Location

Unknown Facility

Many Locations, Thailand

Location

Related Publications (1)

• Lee BS, Ling X, Asif S, Kraemer P, Hanisch JU, Inki P. Levonorgestrel-releasing intrauterine system versus conventional medical therapy for heavy menstrual bleeding in the Asia-Pacific region. Int J Gynaecol Obstet. 2013 Apr;121(1):24-30. doi: 10.1016/j.ijgo.2012.10.028. Epub 2013 Jan 20.

  PMID: 23340271 DERIVED

MeSH Terms

Conditions

Menorrhagia

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

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: March 17, 2009
• First Posted: March 18, 2009
• Study Start: November 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

KR (1); PA (1); MY (1); HK (1); TH (1); CN (1); ID (1); TW (1)