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Uterine FibroidsPhase 4NCT03500367

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

A Phase 4 study testing rapamycin in people with Uterine Fibroids, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Uterine Fibroids
What is being tested?
rapamycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
1 Jan 2018to 31 Dec 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
  • 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.
  • According to results of medical history, physical examinations, gynecological examinations and laboratory examinations, patients are in a good overall condition (except uterine fibroids).
Show all 16Show fewer
  • 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.
  • Endometrial biopsy should be conducted to eliminate non-endometrial lesions if necessary.
  • Subjects didn't receive any drug therapy for uterine fibroids three months before the clinical test.
  • Female adults have menstruation (>18 years old) and are not during pregnancy and lactation.
  • 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).
  • Patients have signed the informed consent.

Who cannot join

  • Patients are in a period of pregnancy and lactation (patients delivered, miscarried or breast-feed in three months before the treatment)
  • Patients are allergic to any ingredient of the medicine
  • Patients suffer from a disease requiring immediate blood transfusion
  • 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
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  • 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
  • Alcohol or drug (such as aperient) abuse
  • Undiagnosed abnormal bleeding of the reproductive system.
  • Patients also participate in another clinical medicine study
  • Patients took part in another clinical trial that may influence this study before this study

Trial locations and contacts

1 site in 1 country.

Fengzh Feng, MD contact

18612671869 ext. ＋86

fengfzh@pumch.cn

Lan Zhu, MD contact

zhu_julie@sina.com

China1 site, 1 recruiting

  • Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

    Beijing, China/Beiing, 100000

    Fengzh Feng, MD, 18612671869 ext. +86, fengfzh@pumch.cn

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Being tested
rapamycin
Keywords
mammilian target of rapamycin inhibitor, Rapamycin (sirolimus), Treatment, Complications
Medical subject headings
Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rapamycinDrug

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

Study groups in NCT03500367
Study groupRoleWhat they receive
rapamycinExperimentalrapamycin, 2 mg a day, orally ,for 3months
Receives: Drug: rapamycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. size of uterus and the myoma

    efficacy assessment

    Measured: 2 day

Secondary outcomes (4)

  1. hormone levels

    ovarian function assessment

    Measured: 2 day

  2. menstrual blood volume / haemorrhage

    symptom assessment

    Measured: 1 day

  3. adverse event

    safety assessment

    Measured: 2 day

  4. follicular size

    safety assessment

    Measured: 2 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2018
  2. Study start1 Jan 2018
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03500367
Sponsor's protocol ID
LPMS201802
Status last verified
Apr 2018
First submitted
10 Mar 2018
Last updated
18 Apr 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Network platform, and the website will be attached later

Publications

  • Fritsch M, Schmidt N, Groticke 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.

    PubMed 26588841

  • 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.

    PubMed 23820898

  • 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.

    PubMed 26796059

  • 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.

    PubMed 24784716

  • 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.

    PubMed 27409646

  • Zhang G, Fan R, Yang H, Su H, Yu X, Wang Y, Feng F, Zhu L. Safety and efficacy of sirolimus in recurrent intravenous leiomyomatosis, pulmonary benign metastatic leiomyomatosis, and leiomyomatosis peritonealis disseminata: a pilot study. BMC Med. 2024 Mar 13;22(1):119. doi: 10.1186/s12916-024-03344-9.

    PubMed 38481209

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rapamycin in people with Uterine Fibroids, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fengzh Feng, MD (18612671869 ext. ＋86, fengfzh@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

size of uterus and the myoma (time frame: 2 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03500367, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.

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