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


N/A
40 Years
50 Years
Not Enrolling
Female
Endometrial Hyperplasia

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

At 3 and 6 months

Safety Issue:

No

Principal Investigator

Hatem Abu Hashim, MD. MRCOG

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mansoura University Hospitals

Authority:

Egypt: Institutional Review Board

Study ID:

MU-324v

NCT ID:

NCT01499602

Start Date:

May 2009

Completion Date:

November 2011

Related Keywords:

  • Endometrial Hyperplasia
  • Endometrial hyperplasia,
  • LNG-IUS,
  • Progestin
  • Endometrial Hyperplasia
  • Hyperplasia
  • Adenoma

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