A prospective non-randomized open label clinical trial to research the efficacy and safety of sirolimus in patients with symptomatic, recurrent uterine fibroids or/and various rare leiomyoma.
Recent studies indicate that mTOR pathway is a specific and sensitive tumor target molecule in uterine fibroids, which can be used as a target molecule for interventional therapy and can provide a new cut-in point for nonoperative treatment. However, the application of mTOR inhibitor (sirolimus) in the treatment of uterine fibroids remains blank. Our study was designed as a prospective non-randomized open label clinical trial to research its efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
rapamycin, 2 mg a day, orally ,for 3months
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Beijing, China/Beiing, China
RECRUITINGsize of uterus and the myoma
efficacy assessment
Time frame: 2 day
hormone levels
ovarian function assessment
Time frame: 2 day
menstrual blood volume / haemorrhage
symptom assessment
Time frame: 1 day
adverse event
safety assessment
Time frame: 2 day
follicular size
safety assessment
Time frame: 2 day
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