Efficacy and Safety of Rapamycin (Sirolimus) in the Treatment of Symptomatic Uterine Fibroids and Leiomyomatosis
- Registration Number
- NCT03500367
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description rapamycin rapamycin rapamycin, 2 mg a day, orally ,for 3months
- Primary Outcome Measures
Name Time Method size of uterus and the myoma 2 day efficacy assessment
- Secondary Outcome Measures
Name Time Method hormone levels 2 day ovarian function assessment
menstrual blood volume / haemorrhage 1 day symptom assessment
adverse event 2 day safety assessment
follicular size 2 day safety assessment
Trial Locations
- Locations (1)
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
🇨🇳Beijing, China/Beiing, China