Efficacy of LNG-IUS for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women
Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT01499602
Collaborator
(none)
120
1
2
30
4
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
LNG-IUS or Norethisterone Acetate for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women
Study Start Date
:
May 1, 2009
Actual Primary Completion Date
:
Nov 1, 2011
Actual Study Completion Date
:
Nov 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Change in endometrial histopathology pattern from endometrial hyperplasia into regression status. [At 3 and 6 months]
Secondary Outcome Measures
- Time to achieve complete regression [During the follow up period at 3,6,12 months after treatment]
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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 Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
Responsible Party:
Hatem AbuHashim,
Associate Professor of Obstetrics & Gynecology.,
Mansoura University
ClinicalTrials.gov Identifier:
NCT01499602
Other Study ID Numbers:
- MU-324v
First Posted:
Dec 26, 2011
Last Update Posted:
Dec 26, 2011
Last Verified:
Dec 1, 2011
Keywords provided by Hatem AbuHashim,
Associate Professor of Obstetrics & Gynecology.,
Mansoura University
Additional relevant MeSH terms: