Open Label Immunotherapy of Endometriosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Open Label, One-arm, 2-month Study of Once-daily Tablet of V-Endo as Immunotherapy of Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Biological: V-Endo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 50 years pain visual analog scale (VAS) score over 4 (visual linear scale from 0 to 10) confirmation of endometriosis by laparoscopy no drugs used at least for one month prior to enrollment, i.e., estro-progestinic, progestinic, gonadotropin-releasing hormone (GnRH) agonists and antagonists as well as nonsteroidal anti-inflammatory drugs (NSAIDs) Exclusion Criteria: presence of other associated diseases such as malignancies concomitant use of hormonal drugs menopause pregnancy surgery for endometriosis within the last month prior to study entry unable or unwilling to give written consent patients adverse reaction or hypersensitivity to active substance or excipients of V-Endo

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: open-label, single arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One arm open label V-Endo recepients<br>This is single arm open label trial wherein active drug is V-Endo | Biological: V-Endo<br>* V-Endo is a tableted immunotherapeutic derived from hydrolyzed, heat-inactivated, pooled blood from women with endometriosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammation, autoimmunity, immunotherapy, infertility, pelvic pain