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Trial record 94 of 403 for:    LEVONORGESTREL

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

Tracking Information
First Submitted Date March 23, 2009
First Posted Date March 24, 2009
Last Update Posted Date February 18, 2015
Study Start Date August 2004
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 23, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00868153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 23, 2009)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mirena in Idiopathic Menorrhagia
Official Title Levonorgestrel Releasing Intrauterine Device (Mirena) in Idiopathic Menorrhagia
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Serum
Sampling Method Non-Probability Sample
Study Population Women diagnosed with idiopathic menorrhagia, age 30-45, BMI 18-34
Condition Idiopathic Menorrhagia
Intervention Drug: Levonorgestrel IUS (Mirena , BAY86-5028)
One group
Study Groups/Cohorts Group 1
Intervention: Drug: Levonorgestrel IUS (Mirena , BAY86-5028)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 16, 2015)
1125
Original Actual Enrollment
 (submitted: March 23, 2009)
1000
Actual Study Completion Date November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 30 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Bulgaria,   Croatia,   India,   Jordan,   Kuwait,   Pakistan,   Romania,   Russian Federation,   Saudi Arabia,   Serbia,   Sri Lanka,   Turkey,   United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number NCT00868153
Other Study ID Numbers 14494
MA0501
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date February 2015