NCT03340324

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

2.2 years

First QC Date

October 11, 2017

Last Update Submit

April 14, 2019

Conditions

Endometriosis

Keywords

inflammationautoimmunityimmunotherapyinfertilitypelvic pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Effect of V-Endo on complete blood count (CBC)

    2 months

  • Changes induced By V-Endo on life quality

    2 months

  • Effect of V-Endo liver and kidney biochemistry parameters

    2 months

Study Arms (1)

One arm open label V-Endo recepients

EXPERIMENTAL

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

Biological: V-Endo

Interventions

V-EndoBIOLOGICAL

V-Endo is a tableted immunotherapeutic derived from hydrolyzed, heat-inactivated, pooled blood from women with endometriosis

One arm open label V-Endo recepients

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly females will be enrolled as only they have endometriosis
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Immunitor LLC

Ulaanbaatar, Mongolia

RECRUITING

MeSH Terms

Conditions

EndometriosisInflammationAutoimmune DiseasesInfertilityPelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsImmune System DiseasesPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • aldar bourinbaiar, MD/PhD

    CEO

    STUDY CHAIR

Central Study Contacts

Aldar Bourinbaiar, MD/PhD

CONTACT

+976 95130306aldar@immunitor.com

Marina Tarakanovskaya, MD

CONTACT

1 3014760930marinatarakanovskaya@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Masking Details
no masking
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open-label, single arm study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2017

First Posted

November 13, 2017

Study Start

October 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

MO(1)