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

December 20, 2011
December 22, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01499602 on ClinicalTrials.gov Archive Site
Time to achieve complete regression [ Time Frame: During the follow up period at 3,6,12 months after treatment ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.
Female
40 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01499602
MU-324v
Yes
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