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

Endometrial Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499602
• Other study ID #: MU-324v
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: December 22, 2011
• Start date: May 2009
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Hyperplasia

Intervention

Drug:
• LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland
Initial release rate of 20µg Levonorgestrel per day for one year follow up.
• 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

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals,OB/GYN department	Mansoura	Dakahlia Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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):655-62. doi: 10.1097/AOG.0b013e318198a10a. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in endometrial histopathology pattern from endometrial hyperplasia into regression status.		At 3 and 6 months	No
Secondary	Time to achieve complete regression		During the follow up period at 3,6,12 months after treatment	No