Leiomyoma Clinical Trial
Official title:
Open Label Phase II Clinical Trial of Myoma Immunotherapy
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04172272 -
The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures
|
N/A | |
| Terminated |
NCT02940041 -
Concordance Between Sonography Amd MRI for Presurgical Diagnosis of Uterine Mesenchymal Malignant Tumors
|
||
| Withdrawn |
NCT00768742 -
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
|
N/A | |
| Completed |
NCT00156195 -
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids
|
Phase 3 | |
| Completed |
NCT00152256 -
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
|
Phase 3 | |
| Completed |
NCT00160381 -
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
|
Phase 3 | |
| Recruiting |
NCT04214457 -
Development of a Predictive Model for Early Differential Diagnosis of Uterine Leiomyomas and Leiomyosarcomas
|
||
| Completed |
NCT00044876 -
Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist
|
Phase 2 | |
| Completed |
NCT02889848 -
Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) to Treat Uterine Leiomyoma (Fibroids)
|
Phase 1 | |
| Recruiting |
NCT04145518 -
Mechanistic Characterization of Uterine Pain
|
Phase 4 | |
| Completed |
NCT01816815 -
Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670
|
Phase 1 | |
| Completed |
NCT00891657 -
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
|
N/A | |
| Completed |
NCT00156156 -
Study of Asoprisnil in the Treatment of Uterine Fibroids.
|
Phase 3 | |
| Recruiting |
NCT05538689 -
Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)
|
Phase 4 | |
| Active, not recruiting |
NCT03323905 -
Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas
|
N/A | |
| Terminated |
NCT03342859 -
Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned
|
Phase 1 | |
| Recruiting |
NCT06135870 -
Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)
|
||
| Completed |
NCT02777203 -
Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy
|
N/A | |
| Completed |
NCT02189083 -
Study of Tumor-shrinking Decoction (TSD) to Treat Symptomatic Uterine Fibroids
|
Phase 3 | |
| Completed |
NCT01123603 -
Lower Urinary Tract Infection (UTI) Evaluation in Women With Uterine Leiomyomata
|
N/A |