Mirena in Idiopathic Menorrhagia

Bayer

Status: Completed

Conditions: Idiopathic Menorrhagia

Treatments: Drug: Levonorgestrel IUS (Mirena , BAY86-5028)

Study type: Observational

Funder types: Industry

Identifiers

NCT00868153

MA0501

14494

Details and patient eligibility

About

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.

Enrollment: 1,125 patients

Sex: Female

Ages: 30 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,125 participants in 1 patient group

Group 1

Treatment:

Drug: Levonorgestrel IUS (Mirena , BAY86-5028)