Clinical Trial: A Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia
Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Multicenter Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia
Brief Summary:
Randomized controlled multi-center study with three arms including 200 patients with low risk endometrial hyperplasia. After confirmed diagnosis the patients will receive one of the following treatments:
- Provera (Medroxyprogesterone (MPA)/progestin) 10 mg per oral treatment for 6 months 10 day each cycle,
- MPA 10 mg continuously for 6 months,
- Mirena (Levonorgestrel) impregnated IUD for 6 months.
Detailed Summary:
Background:
Endometrial cancer is the most common gynecologic cancer in the Western world and the incidence is still increasing. Endometrial cancer is principally developing through preliminary stages called endometrial hyperplasia and 10-30 per cent will develop into carcinoma when left untreated. The incidence of endometrial cancer in Norway is presently about 650 cases per year and about 3000 cases of endometrial hyperplasia are estimated. Thus,correct and optimal treatment of endometrial hyperplasia will contribute to prevent endometrial cancer development and also in the long term, to reduce the incidence of endometrial cancer. Correct treatment of endometrial hyperplasia includes operative treatment with hysterectomy of the high risk cases and conservative treatment and follow up for patients with lower risk. As diagnostics of endometrial hyperplasia has been a challenge to pathologists, overtreatment of patients with low risk of cancer development is unfortunately still a problem. In the present study an objective scoring system, D-score, is used to classify the patients into low and high risk hyperplasia. D-score in an objective morphometric analysis and the scoring system has proved reliable to predict the prognosis of each single case as to cancer development or not. By tradition low risk endometrial hyperplasia is treated conservatively with progestin hormones, however, no national routines really exist according to dose, type of progestin, treatment time or distribution route, however, varying doses of per oral treatment is mostly used.
Progestins hormones are known to have a growth regulatory effect on the uterine mucosa. However, treatment success after per oral therapy has shown that up to 50% are non-responders after per oral treatment. On the other hand a few recent studies have reported successful results
Sponsor: University Hospital of North Norway
Current Primary Outcome: Regression of hyperplasia related to treatment arm after 6 months of therapy [ Time Frame: Six months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Recurrence of hyperplasia related to treatment arm during follow-up period [ Time Frame: Two years ]
- Side effects during treatment [ Time Frame: Two years ]
Original Secondary Outcome: Same as current
Information By: University Hospital of North Norway
Dates:
Date Received: February 23, 2010
Date Started: May 2005
Date Completion: December 2014
Last Updated: May 11, 2012
Last Verified: May 2012
