Efficacy and Safety of Rapamycin (Sirolimus) in the Treatment of Symptomatic Uterine Fibroids and Leiomyomatosis

Phase 4

• Conditions: Uterine Fibroids
• Interventions: Drug: rapamycin

• 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-03-10
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-14
• Last Update Submitted: 2018-04-14
• Study First Posted: 2018-04-18
• Last Update Posted: 2018-04-18
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

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
adverse event	2 day	safety assessment
hormone levels	2 day	ovarian function assessment
menstrual blood volume / haemorrhage	1 day	symptom 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