EndometriosisPhase 2NCT03340324
Open Label Immunotherapy of Endometriosis
A Phase 2 study testing V-Endo in people with Endometriosis, run by Immunitor LLC at 1 site in Mongolia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- V-Endo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMongolia
- Study dates
- 1 Oct 2017to 1 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Mongolia1 site, 1 recruiting
- Recruiting
Immunitor LLC
Ulaanbaatar
Aldar Bourinbaiar, MD, 97695130306, aldar@immunitor.com
Marina Tarakanovskaya, MD, marinatarakanovskaya@yahoo.com
About this study
Official title: Open Label, One-arm, 2-month Study of Once-daily Tablet of V-Endo as Immunotherapy of Endometriosis
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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- V-Endo
- Keywords
- inflammation, autoimmunity, immunotherapy, infertility, pelvic pain
- Medical subject headings
- Endometriosis, Inflammation, Autoimmune Diseases, Infertility, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-EndoBiological
V-Endo is a tableted immunotherapeutic derived from hydrolyzed, heat-inactivated, pooled blood from women with endometriosis
| Study group | Role | What they receive |
|---|---|---|
| One arm open label V-Endo recepients | Experimental | This is single arm open label trial wherein active drug is V-Endo Receives: Biological: V-Endo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 months
Secondary outcomes (3)
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
Measured: 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/
Measured: 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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start1 Oct 2017
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label, single arm study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunitor LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ekomed LLC
- Responsible party
- Sponsor
- Investigators
- aldar bourinbaiar, MD/PhD, Study chair, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340324
- Sponsor's protocol ID
- V-Endo
- Status last verified
- Apr 2019
- First submitted
- 11 Oct 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once trial is terminated data will be available to share
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, One-arm, 2-month Study of Once-daily Tablet of V-Endo as Immunotherapy of Endometriosis
- ClinicalTrials.gov ID
- NCT03340324
- Acronym / sponsor ID
- V-Endo
- Conditions
- Endometriosis
- Keywords
- inflammation, autoimmunity, immunotherapy, infertility, pelvic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Immunitor LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ekomed LLC
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label, single arm study
| Arm | Type | Receives |
|---|---|---|
| One arm open label V-Endo recepients | Experimental | Biological: V-EndoThis is single arm open label trial wherein active drug is V-Endo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V-EndoV-Endo is a tableted immunotherapeutic derived from hydrolyzed, heat-inactivated, pooled blood from women with endometriosis | Biological | One arm open label V-Endo recepients |
Primary outcome
Effect on pelvic pain by visual analogue scale (VAS)
Time frame: 2 months
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).
3 secondary outcomes
Effect of V-Endo on complete blood count (CBC)
Time frame: 2 months
Changes induced By V-Endo on life quality
Time frame: 2 months
Effect of V-Endo liver and kidney biochemistry parameters
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: Undecided. Once trial is terminated data will be available to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
aldar bourinbaiar, MD/PhD study chair
CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing V-Endo in people with Endometriosis, run by Immunitor LLC at 1 site in Mongolia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mongolia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aldar Bourinbaiar, MD/PhD (+976 95130306, aldar@immunitor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on pelvic pain by visual analogue scale (VAS) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.