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Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)

This study has been withdrawn prior to enrollment.
(Study has never received funding and has never been initiated)
Sponsor:
Collaborator:
Center for Research on Women and Newborn Health
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00123175
First received: July 20, 2005
Last updated: January 7, 2013
Last verified: January 2013

July 20, 2005
January 7, 2013
September 2009
September 2011   (final data collection date for primary outcome measure)
Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Pathologic examination of the specimens obtained by endometrial biposy to determine the regression of endometrial hyperplasia without atypia compared to Provera.
Complete list of historical versions of study NCT00123175 on ClinicalTrials.gov Archive Site
  • Side effects [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Bleeding profile [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Estradiol and progesterone levels [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Side effects, bleeding profile, estradiol and progesterone levels
Not Provided
Not Provided
 
Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)
Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia

The purpose of this research is to determine the effectiveness of the intrauterine device (IUD) called Mirena when compared to the Provera tablets used in treating this condition.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Endometrial Hyperplasia
Device: Intrauterine Device
Mirena and Provera
Other Name: Medroxyprogesterone Acetate and Progestins
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00123175
21012
No
Richard S. Legro, M.D., Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
Center for Research on Women and Newborn Health
Principal Investigator: Richard Legro, M.D. Penn State University College of Medicine
Milton S. Hershey Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP