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OpenTrials
Completed

NCT Number: NCT00874653

Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding

The purposes of this study are:

* To evaluate patient satisfaction for efficacy and tolerability of heavy menstrual bleeding treatment by Mirena. * To collect italian data for Mirena in clinical routine.

Completed

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

30 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women diagnosed with Idiopathic Menorrhagia and Mirena inserted for a period no longer than three months according to the assessment of the investigator and according to the international and national guidelines. These women should also accept to be on contraception during the time period that they have Mirena in situ
  • Body Mass Index = 18-30

Exclusion criteria

  • One or more of the following disorders: Current or recurrent pelvic inflammatory disease; infection of the lower genital tract; postpartum endometritis; septic abortion during the past three months; cervicitis; cervical dysplasia; uterine or cervical malignancy; undiagnosed abnormal uterine bleeding; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; conditions associated with increased susceptibility to infections; acute liver disease or liver tumor; known hypersensitivity to any of the constituents of the product
  • Nulliparity
  • Consumption of Iron, Antiprostaglandins, hormonal drugs and any medication that could effect bleeding should be stopped at least 3 months before the first visit and should not be used during the course of the study.
  • History of diabetes mellitus, cardiovascular disease and thyroid abnormalities
  • Anticoagulation therapy
  • Cancer history including breast cancer

Treatment and study plan

Levonorgestrel (Mirena, BAY86-5028)

Drug

Women using Mirena for intrauterine treatment of menorrhagia

Primary outcomes

  1. The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36)

    Time frame: at 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Levonorgestrel Releasing Intrauterine System (MIRENA) in Idiopathic Menorrhagia

Important dates

Study start
2008
Study completion
2008
First posted
Apr 2, 2009
Registry last updated
Jun 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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