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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00123175
First Posted: July 22, 2005
Last Update Posted: January 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Center for Research on Women and Newborn Health
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
July 20, 2005
July 22, 2005
January 8, 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 ]
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 ]
  • Bleeding profile [ Time Frame: 90 days ]
  • Estradiol and progesterone levels [ Time Frame: 90 days ]
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00123175
21012
No
Not Provided
Not Provided
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