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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01499602
First Posted: December 26, 2011
Last Update Posted: December 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hatem AbuHashim, Mansoura University
December 20, 2011
December 26, 2011
December 26, 2011
May 2009
November 2011   (Final data collection date for primary outcome measure)
Change in endometrial histopathology pattern from endometrial hyperplasia into regression status. [ Time Frame: At 3 and 6 months ]
Same as current
No Changes Posted
Time to achieve complete regression [ Time Frame: During the follow up period at 3,6,12 months after treatment ]
Same as current
Not Provided
Not Provided
 
Efficacy of LNG-IUS for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women
LNG-IUS or Norethisterone Acetate 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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Endometrial Hyperplasia
  • 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
  • Experimental: LNG-IUS
    Release rate of 20µg Levonorgestrel(Mirena, Bayer Schering Pharma Oy, Finland) per day with one year follow up.
    Intervention: Drug: LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland
  • 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
    Intervention: Drug: Norethisterone Acetate tablets

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
November 2011
November 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
40 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
 
NCT01499602
MU-324v
Yes
Not Provided
Not Provided
Hatem AbuHashim, Mansoura University
Mansoura University
Not Provided
Principal Investigator: Hatem Abu Hashim, MD. MRCOG Mansoura University Hospitals
Mansoura University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP