Mirena in Idiopathic Menorrhagia

Idiopathic Menorrhagia Clinical Trial

Official title:

Levonorgestrel Releasing Intrauterine Device (Mirena) in Idiopathic Menorrhagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868153
• Other study ID #: 14494
• Secondary ID: MA0501
• Status: Completed
• Phase: N/A
• First received: March 23, 2009
• Last updated: February 16, 2015
• Start date: August 2004
• Est. completion date: November 2008

Study information

• Verified date: February 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyCroatia: Agency for Medicinal Product and Medical DevicesCroatia: Ethics CommitteeIndia: Ministry of HealthJordan: Ethical CommitteePakistan: Ministry of HealthRomania: National Ethics CommitteeRomania: National Medicines AgencyRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationSerbia: Ethics CommitteeSerbia and Montenegro: Agency for Drugs and Medicinal DevicesTurkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1125
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 45 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Idiopathic Menorrhagia
• Menorrhagia

Intervention

Drug:
• Levonorgestrel IUS (Mirena , BAY86-5028)
One group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Bulgaria,  Croatia,  India,  Jordan,  Kuwait,  Pakistan,  Romania,  Russian Federation,  Saudi Arabia,  Serbia,  Sri Lanka,  Turkey,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena		At vist 1 and 4	No
Secondary	Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study		Every visit	No
Secondary	The health-related quality of life questionnaire SF-36 at Visits 1 and 4		Visit 1 and 4	No
Secondary	The user satisfaction as recorded at Visit 4		visit 4	No
Secondary	Adverse reactions recorded in an ongoing way throughout the duration of the study		every visit	Yes
Secondary	Laboratory parameters as measured at Visits 1 and 4		visit 1 and 4	Yes

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