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

Overview

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.

Full Title of Study: “LNG-IUS or Norethisterone Acetate for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 2011

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

Arms, Groups and Cohorts

  • Experimental: LNG-IUS
    • Release rate of 20µg Levonorgestrel(Mirena, Bayer Schering Pharma Oy, Finland) per day with 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

Clinical Trial Outcome Measures

Primary Measures

  • Change in endometrial histopathology pattern from endometrial hyperplasia into regression status.
    • Time Frame: At 3 and 6 months

Secondary Measures

  • Time to achieve complete regression
    • Time Frame: During the follow up period at 3,6,12 months after treatment

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 40 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hatem AbuHashim, Associate Professor of Obstetrics & Gynecology. – Mansoura University
  • Overall Official(s)
    • Hatem Abu Hashim, MD. MRCOG, Principal Investigator, Mansoura University Hospital

References

Reed SD, Voigt LF, Newton KM, Garcia RH, Allison HK, Epplein M, Jordan D, Swisher E, Weiss NS. Progestin therapy of complex endometrial hyperplasia with and without atypia. Obstet Gynecol. 2009 Mar;113(3):655-662. doi: 10.1097/AOG.0b013e318198a10a.

Lee SY, Kim MK, Park H, Yoon BS, Seong SJ, Kang JH, Jun HS, Park CT. The effectiveness of levonorgestrel releasing intrauterine system in the treatment of endometrial hyperplasia in Korean women. J Gynecol Oncol. 2010 Jun;21(2):102-5. doi: 10.3802/jgo.2010.21.2.102. Epub 2010 Jun 30.

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