Open Label Immunotherapy of Endometriosis

Immunitor

Status and phase: Unknown; Phase 2

Conditions: Endometriosis

Treatments: Biological: V-Endo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03340324

V-Endo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

One arm open label V-Endo recepients

Experimental group

Description:

This is single arm open label trial wherein active drug is V-Endo

Treatment:

Biological: V-Endo