Clinical trial NCT03340324: Open Label Immunotherapy of Endometriosis
Official title: Open Label, One-arm, 2-month Study of Once-daily Tablet of V-Endo as Immunotherapy of Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Endometriosis
Keywords: inflammation
autoimmunity
immunotherapy
infertility
pelvic pain
Lead sponsor: Immunitor LLC
Sponsor class: INDUSTRY
Collaborators: name: Ekomed LLC
First posted: 2017-11-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label, single arm study
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect on pelvic pain by visual analogue scale (VAS)
timeFrame: 2 months
Secondary outcomes:
measure: Effect of V-Endo on complete blood count (CBC)
timeFrame: 2 months
measure: Changes induced By V-Endo on life quality
timeFrame: 2 months
measure: Effect of V-Endo liver and kidney biochemistry parameters
timeFrame: 2 months
Other outcomes:
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Immunitor LLC
Study officials:
affiliation: CEO
name: aldar bourinbaiar, MD/PhD
role: STUDY_CHAIR
References: