Status:
UNKNOWN
Open Label Immunotherapy of Endometriosis
Lead Sponsor:
Immunitor LLC
Collaborating Sponsors:
Ekomed LLC
Conditions:
Endometriosis
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
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, aff...
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 excess...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03340324
Start Date
October 1 2017
End Date
December 1 2019
Last Update
April 16 2019
Active Locations (1)
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1
Immunitor LLC
Ulaanbaatar, Mongolia