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

NCT01499602 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-12-26

No results posted yet for this study

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.

Conditions

  • Endometrial Hyperplasia

Interventions

DRUG

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

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

DRUG

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Hatem Abu Hashim, MD. MRCOG · Mansoura University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01499602 on ClinicalTrials.gov