Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hatem AbuHashim, Mansoura University
ClinicalTrials.gov Identifier:
NCT01499602
First received: December 20, 2011
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Endometrial Hyperplasia
Drug: LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland
Drug: Norethisterone Acetate tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: LNG-IUS or Norethisterone Acetate for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Change in endometrial histopathology pattern from endometrial hyperplasia into regression status. [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to achieve complete regression [ Time Frame: During the follow up period at 3,6,12 months after treatment ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: May 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LNG-IUS
Release rate of 20µg Levonorgestrel(Mirena, Bayer Schering Pharma Oy, Finland) per day with one year follow up.
Drug: LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland
Initial release rate of 20µg Levonorgestrel per day for one year follow up.
Active Comparator: Norethisterone Acetate
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
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

  Eligibility

Ages Eligible for Study:   40 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499602

Locations
Egypt
Mansoura University Hospitals,OB/GYN department
Mansoura, Dakahlia Governorate, Egypt, 35511
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Hatem Abu Hashim, MD. MRCOG Mansoura University Hospitals
  More Information

Publications:
Responsible Party: Hatem AbuHashim, Associate Professor of Obstetrics & Gynecology., Mansoura University
ClinicalTrials.gov Identifier: NCT01499602     History of Changes
Other Study ID Numbers: MU-324v
Study First Received: December 20, 2011
Last Updated: December 22, 2011
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
Endometrial hyperplasia,
LNG-IUS,
Progestin

Additional relevant MeSH terms:
Endometrial Hyperplasia
Hyperplasia
Genital Diseases, Female
Pathologic Processes
Uterine Diseases
Norethindrone
Norethindrone acetate
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014