Efficacy of LNG-IUS for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women

Mansoura University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Endometrial Hyperplasia

Interventions

LNG-IUS; Mirena; Bayer Schering Pharma Oy, FinlandDRUG

Initial release rate of 20µg Levonorgestrel per day for one year follow up.

Norethisterone Acetate tabletsDRUG

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

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mansoura University Hospitals,OB/GYN department

Al Mansurah, Dakahlia Governorate, Egypt

Outcomes

Primary Outcomes

Change in endometrial histopathology pattern from endometrial hyperplasia into regression status.

Time frame: At 3 and 6 months

Secondary Outcomes

Time to achieve complete regression

Time frame: During the follow up period at 3,6,12 months after treatment

Data from ClinicalTrials.gov

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