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Open Label Immunotherapy of Myoma

NCT03550703 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-07-06

No results posted yet for this study

Summary

Myoma of the uterus or uterine fibroids are benign tumors that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological diseases. There is an opinion that the true prevalence of myoma is much larger and reaches up to 80%, i.e., practically every second woman has it, often without knowing about. For the treatment of MM, surgical removal of the nodes or removal of the uterus is used. In addition, GnRH-agonist therapy is practiced, as well as embolization to block blood flow in the tumor. We propose to evaluate the immunotherapy approach in an open label Phase II study in 20 women with myoma, for whom no alternative therapy is available.

Conditions

  • Myoma;Uterus
  • Fibroid Uterus
  • Leiomyoma
  • Fibroma

Interventions

BIOLOGICAL

V3-Myoma

Once daily oral pill of V3-Myoma

Sponsors & Collaborators

  • Immunitor LLC

    lead INDUSTRY

Principal Investigators

  • Aldar Bourinbaiar, PhD, MD/PhD · Immunitor LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-12-01
Completion
2019-12-31

Countries

  • Mongolia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03550703 on ClinicalTrials.gov