Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03500367
Other study ID # LPMS201802
Secondary ID
Status Recruiting
Phase Phase 4
First received March 10, 2018
Last updated April 14, 2018
Start date January 1, 2018
Est. completion date December 31, 2022

Study information

Verified date April 2018
Source Peking Union Medical College Hospital
Contact Fengzh Feng, MD
Phone 18612671869
Email fengfzh@pumch.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria

1. Patients who suffer from menorrhagia and pressure symptoms and whose pelvic ultrasound or pelvic MRI indicates uterine fibroids; or who has underwent myomectomy but suffer from menorrhagia and pressure symptoms again with pelvic ultrasound or pelvic MRI indicating uterine fibroids; or whose other imageological examinations or established surgical diagnosis indicate various rare types of myomatosis and who expect a drug therapy.

2. Symptoms of uterine fibroids can be confirmed if one or multiple symptoms below exist:

- MP shows an excessive amount of bleeding during menstruation (>80.0 mL)

- A subject report shows three excessive amounts of bleeding during menstruation in latest six months

- A subject report indicates pelvic pressure symptoms/pain that are likely related to uterine fibroids.

3. According to results of medical history, physical examinations, gynecological examinations and laboratory examinations, patients are in a good overall condition (except uterine fibroids).

4. Cervical smears show a normal result or have no clinical significance, where further follow-up is unnecessary. If there's a normal result in the latest six month in the medical record of a subject, the subject can pass the inspection of cervical smears. A HPV test can be applied to subjects with equivocal ASCUS as an auxiliary test. ASCUS subjects who get a negative result of a HPV test can be included into this study.

5. Endometrial biopsy should be conducted to eliminate non-endometrial lesions if necessary.

6. Subjects didn't receive any drug therapy for uterine fibroids three months before the clinical test.

7. Female adults have menstruation (>18 years old) and are not during pregnancy and lactation.

8. Subjects have good organ function and results of their biochemical examinations meet the following conditions:

- AST=2.5×the upper limit of normal (ULN),

- ALT=2.5×the upper limit of normal (ULN),

- Serum total bilirubin=1.5×the upper limit of normal (ULN),

- Creatinine=1.5×the upper limit of normal (ULN).

9. Patients have signed the informed consent.

Exclusion Criteria

1. Patients are in a period of pregnancy and lactation (patients delivered, miscarried or breast-feed in three months before the treatment)

2. Patients are allergic to any ingredient of the medicine

3. Patients suffer from a disease requiring immediate blood transfusion

4. Patients suffer from a disease that may impact implementation of the study or explanation of results. This type of diseases includes:

- Known severe blood coagulation disorders

- Known anemia that is not caused by HMB

- Known hemoglobinopathy

- Patients suffered or suffer from cancer of the uterus, cervical carcinoma, ovarian cancer or breast cancer 5) An ultrasonic examination shows one or multiple ovarian cysts with a diameter >30 mm 6) Ovarian tumors or pelvic mass of unknown origin 7) Known or suspected endometrial polyp >15 mm

5. Alcohol or drug (such as aperient) abuse

6. Undiagnosed abnormal bleeding of the reproductive system.

7. Patients also participate in another clinical medicine study

8. Patients took part in another clinical trial that may influence this study before this study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
rapamycin
rapamycin, 2 mg a day, orally ,for 3months

Locations

Country Name City State
China Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences Beijing China/Beiing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Fritsch M, Schmidt N, Gröticke I, Frisk AL, Keator CS, Koch M, Slayden OD. Application of a Patient Derived Xenograft Model for Predicative Study of Uterine Fibroid Disease. PLoS One. 2015 Nov 20;10(11):e0142429. doi: 10.1371/journal.pone.0142429. eCollection 2015. — View Citation

Kashani BN, Centini G, Morelli SS, Weiss G, Petraglia F. Role of Medical Management for Uterine Leiomyomas. Best Pract Res Clin Obstet Gynaecol. 2016 Jul;34:85-103. doi: 10.1016/j.bpobgyn.2015.11.016. Epub 2015 Nov 25. Review. — View Citation

Prizant H, Hammes SR. Minireview: Lymphangioleiomyomatosis (LAM): The "Other" Steroid-Sensitive Cancer. Endocrinology. 2016 Sep;157(9):3374-83. doi: 10.1210/en.2016-1395. Epub 2016 Jul 13. Review. — View Citation

Prizant H, Sen A, Light A, Cho SN, DeMayo FJ, Lydon JP, Hammes SR. Uterine-specific loss of Tsc2 leads to myometrial tumors in both the uterus and lungs. Mol Endocrinol. 2013 Sep;27(9):1403-14. doi: 10.1210/me.2013-1059. Epub 2013 Jul 2. — View Citation

Suo G, Sadarangani A, Tang W, Cowan BD, Wang JY. Telomerase expression abrogates rapamycin-induced irreversible growth arrest of uterine fibroid smooth muscle cells. Reprod Sci. 2014 Sep;21(9):1161-70. doi: 10.1177/1933719114532839. Epub 2014 Apr 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary size of uterus and the myoma efficacy assessment 2 day
Secondary hormone levels ovarian function assessment 2 day
Secondary menstrual blood volume / haemorrhage symptom assessment 1 day
Secondary adverse event safety assessment 2 day
Secondary follicular size safety assessment 2 day
See also
  Status Clinical Trial Phase
Completed NCT01441635 - Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids Phase 2
Completed NCT00958334 - Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003 Phase 2
Withdrawn NCT04567589 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
Recruiting NCT05078307 - Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids N/A
Recruiting NCT02283502 - Clinical Test of the MRgHIFU System on Uterine Fibroids Phase 1
Completed NCT01739621 - Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200 Phase 2
Completed NCT01631903 - Extension of Study ZPV-200 Phase 2
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Not yet recruiting NCT03586947 - Association Between Vitamin D and the Risk of Uterine Fibroids N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Not yet recruiting NCT06055114 - Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn NCT04567095 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn NCT03699176 - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Phase 3
Not yet recruiting NCT02884960 - Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization N/A
Completed NCT02472184 - Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy N/A
Terminated NCT01555073 - Preemptive Analgesia Following Uterine Artery Embolization Phase 4
Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A