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OpenTrials
Completed

NCT Number: NCT00868153

Mirena in Idiopathic Menorrhagia

This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.The patients evaluated at four visits, beginning with the insertion visit and 3, 6 and 12 months after insertion.

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Key information

Conditions

Idiopathic Menorrhagia

Age range

30 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Woman diagnosed with idiopathic Menorrhagia according to assessment of the investigator and according to international guidelines. These woman should also accept to be on contraception during the time period that they have Mirena in situ.
  • Age limit 30-45
  • BMI= 18-34
  • Signed informed consent

Exclusion criteria

  • Medical conditions featured in the Mirena data sheet (See Appendix 1) that contraindicate its use, listed below:
  • Known or suspected pregnancy; 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 IUS (Mirena , BAY86-5028)

Drug

One group

Primary outcomes

  1. To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena

    Time frame: At vist 1 and 4

Secondary outcomes

  1. Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study

    Time frame: Every visit

  2. The health-related quality of life questionnaire SF-36 at Visits 1 and 4

    Time frame: Visit 1 and 4

  3. The user satisfaction as recorded at Visit 4

    Time frame: visit 4

  4. Adverse reactions recorded in an ongoing way throughout the duration of the study

    Time frame: every visit

  5. Laboratory parameters as measured at Visits 1 and 4

    Time frame: visit 1 and 4

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Levonorgestrel Releasing Intrauterine Device (Mirena) in Idiopathic Menorrhagia

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Mar 24, 2009
Registry last updated
Feb 18, 2015

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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