MedDataX Logo

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

NCT ID: NCT01499602

Last Updated: 2011-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometrial Hyperplasia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Endometrial hyperplasia, LNG-IUS, Progestin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LNG-IUS

Release rate of 20µg Levonorgestrel(Mirena, Bayer Schering Pharma Oy, Finland) per day with one year follow up.

Group Type EXPERIMENTAL

LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland

Intervention Type DRUG

Initial release rate of 20µg Levonorgestrel per day for one year follow up.

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

Group Type ACTIVE_COMPARATOR

Norethisterone Acetate tablets

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland

Initial release rate of 20µg Levonorgestrel per day for one year follow up.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hatem AbuHashim

Associate Professor of Obstetrics & Gynecology.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hatem Abu Hashim, MD. MRCOG

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mansoura University Hospitals,OB/GYN department

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19300331 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20613900 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MU-324v

Identifier Type: -

Identifier Source: org_study_id