A Phase 2 interventional study of V-Endo in Endometriosis, sponsored by Immunitor LLC. Status unknown at 1 site in Mongolia. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Immunitor LLC · Phase 2, Interventional, and Treatment
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.
920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.
This study's planned enrollment of 30 is below the median of 67 across 540 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Immunitor LLC is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is single arm open label trial wherein active drug is V-Endo
Biological: V-Endo
V-Endo is a tableted immunotherapeutic derived from hydrolyzed, heat-inactivated, pooled blood from women with endometriosis
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).
Time frame: 2 months
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
Time frame: 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/
Time frame: 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
Time frame: 2 months
Plan to share: Undecided — Once trial is terminated data will be available to share
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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