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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00123175
Study type Interventional
Source Milton S. Hershey Medical Center
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date September 2009
Completion date September 2011

See also
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Completed NCT01074892 - A Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia Phase 4
Not yet recruiting NCT05903131 - A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia Phase 2
Not yet recruiting NCT05829460 - Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia Phase 2
Withdrawn NCT04897217 - Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia Phase 3
Recruiting NCT03176992 - Surgicel® & Endometrial Ablation in the Management of Perimenpausal Heavy Menstrual Bleeding Phase 2
Not yet recruiting NCT00919919 - Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Phase 2
Recruiting NCT03207126 - Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy? N/A
Recruiting NCT03207061 - Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in Endometrial Cancer? N/A
Completed NCT03207074 - Can the iKnife Distinguish Between Normal and Malignant Endometrial Tissue? N/A