Clinical Trial: Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Milton S. Hershey Medical Center
Current Primary Outcome: 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 ]
Original Primary Outcome: Pathologic examination of the specimens obtained by endometrial biposy to determine the regression of endometrial hyperplasia without atypia compared to Provera.
Current Secondary Outcome:
- Side effects [ Time Frame: 90 days ]
- Bleeding profile [ Time Frame: 90 days ]
- Estradiol and progesterone levels [ Time Frame: 90 days ]
Original Secondary Outcome: Side effects, bleeding profile, estradiol and progesterone levels
Information By: Milton S. Hershey Medical Center
Dates:
Date Received: July 20, 2005
Date Started: September 2009
Date Completion: September 2011
Last Updated: January 7, 2013
Last Verified: January 2013
