Adenomyosis Clinical Trial
Official title:
Mifepristone Versus Placebo to Treat Adenomyosis: a Double-blind, Multicentreļ¼Randomized Clinical Trial
This clinical trial is designed to study the effectiveness and safety of mifepristone in the
treatment of symptomatic adenomyosis with multi center, random, double blind and controlled
clinical trials. This multicenter study is performed in 150 subjects who are diagnosed as
adenomyosis . Twelve weeks of randomization, allocation concealment, double-blind,
placebo-controlled, parallel grouping. Subjects are randomly assigned to one of two treatment
groups and received one of the following treatments:
1. Mifepristone tablets of 10mg, 1 tablet daily, oral
2. Placebo, 1 tablet daily, oral
Adenomyosis is a common benign disease of Gynecology, with secondary progressive dysmenorrhea
and menorrhagia as the main clinical manifestations, which seriously harm the physical and
mental health of the patients. Most patients have the desire to retain the uterus. Therefore,
the treatment of drug conservative treatment is dominant in the treatment of adenomyosis.
However, the current clinical treatment of adenomyosis still has some limitations and needs
to be improved. Therefore, it is imperative to expand the clinical medication of adenomyosis.
Mifepristone is defined as a selective progesterone receptor modulator. Under specific
conditions, it plays the role of anti progestin, inhibits endometrial proliferation, inhibits
ovulation, and can cause reversible amenorrhea. In recent years, it has been widely used in
of uterine leiomyoma and endometriosis. Adenomyosis is also closely related to hormone
related diseases, especially endometriosis. At present, the study of mifepristone in the
treatment of adenomyosis is more extensive in China. A large number of domestic literature
reports that low dose mifepristone for the treatment of adenomyosis is safe and effective for
the treatment of adenomyosis . During the treatment of mifepristone, most of the patients had
amenorrhea, obviously alleviating dysmenorrhea and reducing the menstrual volume, reducing
the uterine and lesion volume of the patients with adenomyosis . However, most of the
domestic literature is a small sample case control study or retrospective study. There is no
randomized double blind control study. There is no clinical study on the application of
mifepristone to adenomyosis in foreign countries. Therefore, the clinical evidence is
inadequate, and a high quality randomized controlled trial is still needed. The purpose of
this study is to demonstrate the effectiveness and safety of mifepristone (10mg) in the
treatment of symptomatic adenomyosis with multi center, random, double blind and controlled
clinical trials. It is a new clinical study for the old medicine.
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