Mirena in Idiopathic Menorrhagia - Full Text View

Purpose

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	Phase
Idiopathic Menorrhagia	Drug: Levonorgestrel IUS (Mirena , BAY86-5028)	Phase 4

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:

Drug Information available for: Levonorgestrel

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
The health-related quality of life questionnaire SF-36 at Visits 1 and 4 [ Time Frame: Visit 1 and 4 ] [ Designated as safety issue: No ]
The user satisfaction as recorded at Visit 4 [ Time Frame: visit 4 ] [ Designated as safety issue: No ]
Adverse reactions recorded in an ongoing way throughout the duration of the study [ Time Frame: every visit ] [ Designated as safety issue: Yes ]
Laboratory parameters as measured at Visits 1 and 4 [ Time Frame: visit 1 and 4 ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Serum

Enrollment:	1000
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

Eligibility

Ages Eligible for Study:	30 Years to 45 Years
Genders 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier:	NCT00868153 History of Changes
Other Study ID Numbers:	14494, MA0501
Study First Received:	March 23, 2009
Last Updated:	April 12, 2010
Health Authority:	Bulgaria: Bulgarian Drug Agency Croatia: Agency for Medicinal Product and Medical Devices Croatia: Ethics Committee India: Ministry of Health Jordan: Ethical Committee Pakistan: Ministry of Health Romania: National Ethics Committee Romania: National Medicines Agency Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Serbia: Ethics Committee Serbia and Montenegro: Agency for Drugs and Medicinal Devices Turkey: Ethics Committee Turkey: Ministry of Health

Additional relevant MeSH terms:

Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Levonorgestrel
Contraceptive Agents, Female

Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 16, 2013