NCT01499602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
Last Updated

December 26, 2011

Status Verified

December 1, 2011

Enrollment Period

2.5 years

First QC Date

December 20, 2011

Last Update Submit

December 22, 2011

Conditions

Endometrial Hyperplasia

Keywords

Endometrial hyperplasia,LNG-IUS,Progestin

Outcome Measures

Primary Outcomes (1)

  • Change in endometrial histopathology pattern from endometrial hyperplasia into regression status.

    At 3 and 6 months

Secondary Outcomes (1)

  • Time to achieve complete regression

    During the follow up period at 3,6,12 months after treatment

Study Arms (2)

LNG-IUS

EXPERIMENTAL

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

Norethisterone Acetate

ACTIVE COMPARATOR

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

Interventions

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

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

LNG-IUS
Norethisterone Acetate tabletsDRUG

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

Norethisterone Acetate

Eligibility Criteria

Age40 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with histologically confirmed simple or complex endometrial hyperplasia without atypia

You may not qualify if:

  • Endometrial hyperplasia with atypia
  • Other pathology e.g. patients with fibroids of any size, genital infection, adnexal abnormality.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospitals,OB/GYN department

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 19300331BACKGROUND

  • 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.

    PMID: 20613900BACKGROUND

MeSH Terms

Conditions

Endometrial Hyperplasia

Interventions

LevonorgestrelNorethindrone Acetate

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorethindrone

Study Officials

  • Hatem Abu Hashim, MD. MRCOG

    Mansoura University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Obstetrics & Gynecology.

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 26, 2011

Study Start

May 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

December 26, 2011

Record last verified: 2011-12

Locations

EG(1)