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; Drug: Norethisterone Acetate tablets

• 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

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2011-12
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-22
• Last Update Submitted: 2011-12-22
• Study First Posted: 2011-12-26
• Last Update Posted: 2011-12-26

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