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| Name | Class |
|---|---|
| Ekomed LLC | INDUSTRY |
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Endometriosis is a chronic gynecological disease characterized by sustained painful symptoms that are responsible for a decline in the quality of life of sufferers. Endometriosis is fairly common, affecting an estimated 10%-15% of women and girls, usually during their reproductive years. Based on these rough estimates, the latest epidemiological studies suggest that over 200 million women are might be affected who may commonly have infertility problems. Additionally, endometriosis is a major factor increasing by 33-66% risk of ovarian cancer. V-Endo is a tableted preparation derived from hydrolyzed, heat-inactivated, pooled blood of women with endometriosis. When taken orally it is postulated to cause the immune tolerance and anti-inflammatory effect as a result.
Anatomically endometriosis is characterized by the presence of endometrial-type mucosa outside the uterine cavity. This tissue proliferates and causes chronic inflammation resulting in pain and excessive menstrual bleeding. Conventional treatment includes surgical and pharmacological therapy aiming at reducing painful symptoms. However, there is an unmet need in finding optimally safe and effective treatment. This study aimed to evaluate the effect of V-Endo on pain levels in women with endometriosis, focusing on reducing inflammation by immunotherapeutic intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One arm open label V-Endo recepients | Experimental | This is single arm open label trial wherein active drug is V-Endo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V-Endo | Biological | V-Endo is a tableted immunotherapeutic derived from hydrolyzed, heat-inactivated, pooled blood from women with endometriosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect on pelvic pain by visual analogue scale (VAS) | The pain VAS is a continuous scale comprised of a horizontal or vertical line, usually 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of V-Endo on complete blood count (CBC) | The effect of V-Endo on complete blood cell count and clinical biochemistry will be evaluated by routine lab tests to determine whether they are within normal ranges are as described in http://onlinelibrary.wiley.com/doi/10.1002/9781118704783.app3/pdf | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
Only females will be enrolled as only they have endometriosis
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aldar Bourinbaiar, MD/PhD | Contact | +976 95130306 | aldar@immunitor.com | |
| Marina Tarakanovskaya, MD | Contact | 1 3014760930 | marinatarakanovskaya@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| aldar bourinbaiar, MD/PhD | CEO | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Immunitor LLC | Recruiting | Ulaanbaatar | Mongolia |
Once trial is terminated data will be available to share
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D007249 | Inflammation |
| D001327 | Autoimmune Diseases |
| D007246 | Infertility |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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open-label, single arm study
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no masking
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| Changes induced By V-Endo on life quality |
Changes in life quality occurring as a result of intervention as measured by EHP-30 instrument https://innovation.ox.ac.uk/outcome-measures/endometriosis-health-profile-ehp/ |
| 2 months |
| Effect of V-Endo liver and kidney biochemistry parameters | The influence on kidney and liver biochemistry parameters measured as described in http://onlinelibrary.wiley.com/doi/10.1002/9781118704783.app3/pdf | 2 months |
| D000091662 | Genital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |