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Mirena in Idiopathic Menorrhagia

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: March 23, 2009
Last updated: February 16, 2015
Last verified: February 2015
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Levonorgestrel Releasing Intrauterine Device (Mirena) in Idiopathic Menorrhagia

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study [ Time Frame: Every visit ]
  • The health-related quality of life questionnaire SF-36 at Visits 1 and 4 [ Time Frame: Visit 1 and 4 ]
  • The user satisfaction as recorded at Visit 4 [ Time Frame: visit 4 ]
  • Adverse reactions recorded in an ongoing way throughout the duration of the study [ Time Frame: every visit ]
  • Laboratory parameters as measured at Visits 1 and 4 [ Time Frame: visit 1 and 4 ]

Biospecimen Retention:   None Retained

Enrollment: 1125
Study Start Date: August 2004
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Levonorgestrel IUS (Mirena , BAY86-5028)
One group


Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women diagnosed with idiopathic menorrhagia, age 30-45, BMI 18-34

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00868153

Many Locations, Bulgaria
Many Locations, Croatia
Many Locations, India
Many Locations, Jordan
Many Locations, Kuwait
Many Locations, Pakistan
Many Locations, Romania
Russian Federation
Many Locations, Russian Federation
Saudi Arabia
Many Locations, Saudi Arabia
Many Locations, Serbia
Sri Lanka
Many Locations, Sri Lanka
Many Locations, Turkey
United Arab Emirates
Many Locations, United Arab Emirates
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00868153     History of Changes
Other Study ID Numbers: 14494
Study First Received: March 23, 2009
Last Updated: February 16, 2015

Additional relevant MeSH terms:
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral processed this record on June 23, 2017