A Phase 2 interventional study of V3-Myoma in Myoma;Uterus, Fibroid Uterus and Leiomyoma, sponsored by Immunitor LLC. Status unknown at 1 site in Mongolia. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-07-06.
Sponsored by Immunitor LLC · Phase 2, Interventional, and Treatment
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.
Myoma or uterine fibroids are one of the most common gynecological diseases, which occurs in at least one third of women older than 35 years, and after 40 - in every second. We will test a new tablet preparation, V3-Myoma, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with uterine myoma. When administered orally, V3-Myoma should cause a specific anti-tumor immune response and an anti-inflammatory effect. Such an effect is due to the phenomenon known in immunology, called oral tolerance, leading to a reduction in tumor mass and a decrease in inflammation. An important advantage of our approach is the absence of any negative side effects. In the next three month, we will conduct Phase II open label clinical study of this intervention in 30 women with confirmed diagnosis of myoma.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
This study's planned enrollment of 30 is below the median of 66 across 306 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Immunitor LLC is the lead sponsor of 14 studies on the registry; none are open to participants now.
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diagnosed myoma with single or multiple tumors presence of typical clinical symptoms associated with myoma -
Exclusion Criteria:
other gynecological diseases not related to myoma hysterectomy
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A single oral pill of V3-Myoma therapeutic vaccine containing pooled antigens circulating in peripheral blood and within myoma tissues
Biological: V3-Myoma
Once daily oral pill of V3-Myoma
Change in tumor size compared to baseline
This parameter will be evaluated by pelvic examination and transvaginal ultrasonography
Time frame: Once monthly for three months
Changes in bleeding pattern at and between menstruations
Self-evaluated by patient
Time frame: During and between periods for three months
Changes in level of pain associated with myoma, low back and legs, pelvic pressure and pain, if any
Self evaluated by patient
Time frame: 3 months
Changes in frequent urination or difficulty in emptying the bladder or constipation
Self evaluated by patient
Time frame: 3 months
Plan to share: No — Upon study completion the data will be available in peer-reviewed publication
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This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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