Efficacy of LNG-IUS for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women
Not Applicable
Completed
- Conditions
- Endometrial Hyperplasia
- Interventions
- Drug: LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland
- Registration Number
- NCT01499602
- Lead Sponsor
- Mansoura University
- Brief Summary
The purpose of this study is to compare the efficacy of the Levonorgestrel releasing Intrauterine System (Mirena) and Norethisterone Acetate for treatment of non-atypical endometrial hyperplasia in perimenopausal women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
Inclusion Criteria
- Patients with histologically confirmed simple or complex endometrial hyperplasia without atypia
Exclusion Criteria
- Endometrial hyperplasia with atypia
- Other pathology e.g. patients with fibroids of any size, genital infection, adnexal abnormality.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LNG-IUS LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland Release rate of 20µg Levonorgestrel(Mirena, Bayer Schering Pharma Oy, Finland) per day with one year follow up. Norethisterone Acetate Norethisterone Acetate tablets Norethisterone Acetate tablets at a dose of 5 mg three times daily (15mg/day) for 3 weeks over three months.With persistence of endometrial hyperplasia, the treatment is repeated for another 3 months
- Primary Outcome Measures
Name Time Method Change in endometrial histopathology pattern from endometrial hyperplasia into regression status. At 3 and 6 months
- Secondary Outcome Measures
Name Time Method Time to achieve complete regression During the follow up period at 3,6,12 months after treatment
Trial Locations
- Locations (1)
Mansoura University Hospitals,OB/GYN department
🇪🇬Mansoura, Dakahlia Governorate, Egypt