Skip to main content
OpenTrials
Completed

NCT Number: NCT01499602

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometrial Hyperplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Uterine Diseases

Age range

40 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospitals,OB/GYN department

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Norethisterone Acetate tablets

Drug

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 outcomes

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

    Time frame: At 3 and 6 months

Secondary outcomes

  1. Time to achieve complete regression

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

LNG-IUS or Norethisterone Acetate for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 26, 2011
Registry last updated
Dec 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.