Metformin versus Levonorgestrel-Releasing Intrauterine Device (MIRENA) in the Management of Endometrial Hyperplasia
- Conditions
- endometrial hyperplasia
- Registration Number
- PACTR201908498370196
- Lead Sponsor
- faculty of medicine suez canal university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 50
1-Women between the ages of 18-75 years old.
2-Women with a histological diagnosis of endometrial hyperplasia without atypia confirmed by endometrial biopsy.
1-Pregnant women.
2-Women with contraindication to Metformin (Impaired renal functions , Cirrhosis of the liver, Hepatitis and Alcoholism).
3-Women with contraindications to Mirena (e.g. acute genital tract inflammatory disease, genital bleeding of unknown etiology, hypersensitivity to any component of this product, congenital or acquired uterine anomaly, known or suspected breast cancer, known or suspected uterine and cervical neoplasia or acute liver disease or liver tumor).
4-Women with concurrent endometrial cancer .
5-Women with a history of a hormone-dependent malignancy (e.g. breast cancer).
6-Women taking tamoxifen.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.
- Secondary Outcome Measures
Name Time Method intervention related side effects