A Phase 3 interventional study of Levonorgestrel intrauterine device (IUD) in Atypical Endometrial Polyps and Atypical Endometrial Hyperplasia, sponsored by IRCCS Burlo Garofolo. Completed at 1 site in Italy. Open to female participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2011-09-02.
Sponsored by IRCCS Burlo Garofolo · Phase 3, Interventional, and Treatment
The study aims to evaluate the long-term efficacy and prognosis of hysteroscopic resection and coagulation of the base of endometrial polyps with focal atypia in fertile women.
The introduction of hysteroscopy in clinical practice changed significantly our knowledge of uterine cavity, but did not stimulate the start of big studies with aim to evaluate the feasibility of conservative treatments for better defined diseases as endometrial polyp. The use of curettage(D\&C) has led the gynecologists to consider diffuse atypical endometrial hyperplasia and atypical polyp as the same disease. The treatment of these precancerous lesions recommended by scientific societies is aggressive (hysterectomy). Surprisingly, regarding hysterectomy we did not observe management modifications after the introduction of endoscopic techniques, as happened in other surgical disciplines.
To evaluate costs and health benefits of operational hysteroscopy we started in our Institute a study protocol in 1998. In a first trial we studied a conservative treatment of postmenopausal woman with high anesthesiologic risk who had endometrial polyps with atypia and no involvement of the base (Scrimin F. Am J Obstet Gynecol 2006;195:1328-30).
The good initial results and the request of conservative treatments by some women, desiring pregnancies, encouraged us to start this preliminary trial to evaluate the long-term efficacy and prognosis of hysteroscopic resection and coagulation of the base of endometrial polyps with focal atypia in a little sample of fertile women. Other studies suggest progestin treatment of well differentiated carcinoma in young women who desired to preserve their fertility. There is no evidence of a correlation between the tendency to develop endometrial polyps and the risk of endometrial carcinoma. The risk of malignant degeneration of endometrial polyps is not well known, but seems to range between 0.5% and 6%. On this background, we decided to study in the same population of fertile women and with a quasi-randomised design the possible additional effect of levonorgestrel-releasing intrauterine device (LNG-IUD).
Comparison: women assigned to odd numbers underwent polyp resection and endometrial surveillance with insertion of levonorgestrel intrauterine system (IUD group), women assigned to even numbers underwent polyp resection and endometrial surveillance without insertion of levonorgestrel intrauterine system (no IUD or control group).
255 studies on the registry are indexed under Uterine Neoplasms; 64 are open to participants now.
This study's enrollment of 21 is below the median of 49 across 181 interventional studies indexed under Uterine Neoplasms.
Browse Uterine Neoplasms studies →IRCCS Burlo Garofolo is the lead sponsor of 87 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Device: Levonorgestrel intrauterine device (IUD)
Efficacy and prognosis of hysteroscopic resection of atypical polyps in terms of appearance of endometrial cancer or recurrence of atypical endometrial lesions
Time frame: Five years
Recurrence rate of polyp in the two groups
Time frame: Five years
This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.
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IRCCS Burlo Garofolo