Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia
18 Years
N/A
Female
Endometrial Hyperplasia
Trial Information
Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia
Endometrial hyperplasia without atypia is a condition usually caused by excessive
stimulation of the uterine lining (endometrium) by estrogens, and may cause irregular
bleeding as a presenting symptom, but rarely may progress to endometrial cancer, which makes
treatment important. The only treatment approved so far is medroxyprogesterone acetate
tablets (progesterone), also known as Provera.
Inclusion Criteria:
- Histologic diagnosis of simple or complex endometrial hyperplasia without atypia
- Normal pap smear within one year
Exclusion Criteria:
- Diabetes
- Family history of endometrial cancer
- Contraindications for the intrauterine device
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera
Outcome Time Frame:
90 days
Safety Issue:
No
Principal Investigator
Richard Legro, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Penn State University College of Medicine
Authority:
United States: Institutional Review Board
Study ID:
21012
NCT ID:
NCT00123175
Start Date:
September 2009
Completion Date:
September 2011
Related Keywords:
- Endometrial Hyperplasia
- Endometrial Hyperplasia without atypia
- Endometrial Hyperplasia
- Hyperplasia
- Adenoma
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