ClinicalTrials.gov
ClinicalTrials.gov Menu

Mirena in Idiopathic Menorrhagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00868153
Recruitment Status : Completed
First Posted : March 24, 2009
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment
Idiopathic Menorrhagia Drug: Levonorgestrel IUS (Mirena , BAY86-5028)

Study Type : Observational
Actual Enrollment : 1125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Levonorgestrel Releasing Intrauterine Device (Mirena) in Idiopathic Menorrhagia
Study Start Date : August 2004
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1 Drug: Levonorgestrel IUS (Mirena , BAY86-5028)
One group




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   None Retained
Serum


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868153


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00868153     History of Changes
Other Study ID Numbers: 14494
MA0501
First Posted: March 24, 2009    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Genital Diseases, Female
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Menstruation Disturbances
Pathologic Processes
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral