External Genital EndometriosisNCT04962620

Study of the Efficacy and Safety of Longidaze® for the Treatment of Patients With External Genital Endometriosis

An observational study of External Genital Endometriosis, run by NPO Petrovax at 6 sites in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

A study is being conducted to evaluate the efficacy and safety of Longidaze for the prevention and treatment of external genital endometriosis . Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: External Genital Endometriosis
What is being tested?: Bovhyaluronidase azoximer
How many people: 149 participants
Where: 6 sitesRussia
Study dates: 26 Dec 2019to 1 Aug 2021
Phase: Observational
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: Patients with a verified diagnosis of external genital endometriosis, who, as part of routine clinical practice, were prescribed monotherapy with per os dienogest or combined treatment with a combination of dienogest + vaginal and rectal suppositories Longidaze®, 3000 ME (hereinafter referred to as Longidaze® )

Who may be able to join

Documented informed consent;
Patients over 18 years of age with active menstrual function;
Women with external genital endometriosis, confirmed morphologically and visually during laparoscopic or laparotomy surgery performed 10 years to 2 weeks prior to Day 0;
Patients in the framework of routine clinical practice in accordance with the instructions for use, prior to inclusion in the study, are assigned one of the following therapy regimens:
monotherapy with dienogest 2 mg daily for at least 6 months per os
complex treatment with dienogest 2 mg daily for at least 6 months per os in combination with vaginal and rectal suppositories Longidaze® 1 suppository 1 time every 2 days 10 suppositories, and then 1 suppository 1 time in 7 days 17 suppositories for another 120 days;
Willingness to use barrier methods of contraception.

Who cannot join

Women before menarche or after menopause
Adenomyosis;
Amenorrhea (more than 3 months in a row within 6 months before screening);
Patients who are scheduled to undergo surgery for endometriosis during the study;
Hormone therapy for endometriosis or the use of aromatase inhibitors within 16 weeks prior to Day 0;
Daily use of pain relievers for 7 consecutive days or more due to any other reason other than endometriosis;
6. Participation in clinical trials less than 30 days before the screening visit and / or 5 drug half-lives, whichever is longer.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Russia6 sites

State budgetary healthcare institution "Chelyabinsk Regional Clinical Skin and Venereal Diseases Dispensary"
Chelyabinsk, Chelyabinsk Oblast, 454048
Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia"
Moscow, 109388
Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of the Russian Federation
Moscow, 119048
Private health care institution "Road clinical hospital at the station Nizhny Novgorod of the open joint stock company" Russian Railways "
Nizhny Novgorod, Nizhny Novgorod Oblast, 603140
Federal State Budgetary Scientific Institution "Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott "
Saint Petersburg, Leningradskaya Oblast', 199034
Federal State Budgetary Educational Institution of Higher Education "Voronezh State Medical University named after N.N. Burdenko "of the Ministry of Health of the Russian Federation
Voronezh, Voronezh Oblast, 394036

Other trials in Russia

About this study

Official title: Multicenter Prospective Non-interventional Study of the Efficacy and Safety of Longidaze®, Vaginal and Rectal Suppositories, 3000 IU, for the Treatment of Patients With External Genital Endometriosis

A study is being conducted to evaluate the efficacy and safety of Longidaze for the prevention and treatment of external genital endometriosis .

Read the detailed description

The aim of the study is to compare the outcomes of complex therapy in patients with external genital endometriosis who, in addition to hormonal therapy, were prescribed Longidaze®, vaginal and rectal suppositories, 3000 IU, with the outcomes of therapy in patients who received only hormonal therapy.

Conditions: External Genital Endometriosis
Being tested: Bovhyaluronidase azoximer
Keywords: longidaze, external genital endometriosis, bovhyaluronidase azoximer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bovhyaluronidase azoximerDrug
Rectally or vaginally 1 suppository of Longidaze every 2 days. The main course of treatment - 10 suppositories (for 30 days). Then (according to the doctor's decision) supportive therapy is prescribed for 1 suppository 1 time in 7 days. Course of supportive treatment - 17 suppositories for another 120 days. The patients took dienogest according to the instructions for use.

Study groups in NCT04962620
Study group	Role	What they receive
Longidaze		75 patients receiving combination therapy: Longidaze + dienogest Receives: Drug: Bovhyaluronidase azoximer
Control		74 patients receiving only Dienogest.

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in the severity of endometriosis-associated pelvic pain (Day 30)
Changes in the severity of endometriosis-associated pelvic pain by visual analogue scale (VAS) after 30 days from the baseline value in patients of the dienogest + Longidaze® combination therapy group compared with patients who received only dienogest. The Visual Analogue Scale (VAS) is designed to measure pain intensity. It is a continuous scale in the form of a horizontal line 10 cm (100 mm) long and located on it two extreme points: "no pain" and "the strongest pain you can imagine." The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his pain intensity. The ruler measures the distance (mm) between "no pain" and "the worst pain imaginable," providing a score range from 0 to 100. A higher score indicates more pain intensity.
Measured: Day 0, Day 30

Secondary outcomes (4)

Changes in the severity of endometriosis-associated pelvic pain (Days 90, 150, 180)
Changes in the severity of endometriosis-associated pelvic pain according to the VAS after 90, 150 and 180 days relative to the baseline value in patients of the dienogest + Longidaze® combination therapy group compared with patients who received only dienogest. The Visual Analogue Scale (VAS) is designed to measure pain intensity. It is a continuous scale in the form of a horizontal line 10 cm (100 mm) long and located on it two extreme points: "no pain" and "the strongest pain you can imagine." The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his pain intensity. The ruler measures the distance (mm) between "no pain" and "the worst pain imaginable," providing a score range from 0 to 100. A higher score indicates more pain intensity.
Measured: Day 0, Day 90, Day 150, Day 180
Change in the Biberoglu and Berman scale
Change in the Biberoglu and Berman scale after 30, 90, 150 and 180 days from the baseline value from the start of treatment in patients of the dienogest + Longidaze® combination therapy group compared with patients who received only dienogest. The Biberoglu and Berman scale consists of five 4-point scales for assessing the severity of dysmenorrhea, dyspareunia and chronic pelvic pain not associated with menstruation, as well as the assessment of pain and static hyperalgesia during gynecological examination. In each of the scales, 0 points - no symptom, 3 points - the most pronounced symptom. The result is assessed by the sum of points for each symptom. With a sum of points from 1 to 2, pelvic pain is considered mild, from 3 to 5 - moderate, from 6 to 10 - strong, from 11 to 15 - severe.
Measured: Day 0, Day 30, Day 90, Day 150, Day 180
Change in the score on the SF-36 quality of life questionnaire
Change in the score on the SF-36 quality of life questionnaire after 30, 90, 150 and 180 days relative to the baseline value from the start of treatment in patients of the dienogest + Longidaze® combination therapy group compared with patients who received only dienogest.
Measured: Day 0, Day 30, Day 90, Day 150, Day 180
Change in the severity of uterine bleeding
Change in the severity of uterine bleeding after 30, 90, 150 and 180 days from the start of treatment in patients of the dienogest + Longidaze® combination therapy group compared with patients who received only dienogest. Patients will assess the severity of uterine bleeding in the patient's diary using the Mansfield-Voda-Jorgensen scale. There are five scoring options ranging from light bleeding to heavy bleeding. The rating is determined by the frequency of changing sanitary napkins or tampons, the degree of absorption of these products with blood, and also depends on the absorption properties of these products.
Measured: Day 0, Day 30, Day 90, Day 150, Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Dec 20191 Aug 2021

First posted15 Jul 2021
Study start26 Dec 2019
Primary completion14 May 2021
Study completion1 Aug 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for External Genital 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 149 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04962620
Sponsor's protocol ID: ISLAND
Status last verified: Jul 2021
First submitted: 5 Jul 2021
Last updated: 22 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Prospective Non-interventional Study of the Efficacy and Safety of Longidaze®, Vaginal and Rectal Suppositories, 3000 IU, for the Treatment of Patients With External Genital Endometriosis
ClinicalTrials.gov ID: NCT04962620
Acronym / sponsor ID: ISLAND
Conditions: External Genital Endometriosis
Keywords: longidaze, external genital endometriosis, bovhyaluronidase azoximer
Study type: Observational
Recruitment status: Unknown status
Enrolment: 149 participants (estimated)
Lead sponsor: NPO PetrovaxIndustry (pharma, biotech, devices)
Study start: 26 Dec 2019 (actual)
Primary completion: 14 May 2021 (actual)
Study completion: 1 Aug 2021 (estimated)
First posted: 15 Jul 2021 (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.

A study is being conducted to evaluate the efficacy and safety of Longidaze for the prevention and treatment of external genital endometriosis .

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Longidaze	–	Drug: Bovhyaluronidase azoximer75 patients receiving combination therapy: Longidaze + dienogest
Control	–	–74 patients receiving only Dienogest.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with a verified diagnosis of external genital endometriosis, who, as part of routine clinical practice, were prescribed monotherapy with per os dienogest or combined treatment with a combination of dienogest + vaginal and rectal suppositories Longidaze®, 3000 ME (hereinafter referred to as Longidaze® )

Key inclusion criteria (7 listed)

Documented informed consent;
Patients over 18 years of age with active menstrual function;
Women with external genital endometriosis, confirmed morphologically and visually during laparoscopic or laparotomy surgery performed 10 years to 2 weeks prior to Day 0;
Patients in the framework of routine clinical practice in accordance with the instructions for use, prior to inclusion in the study, are assigned one of the following therapy regimens:
Willingness to use barrier methods of contraception.

Key exclusion criteria (7 listed)

Women before menarche or after menopause
Adenomyosis;
Amenorrhea (more than 3 months in a row within 6 months before screening);
Patients who are scheduled to undergo surgery for endometriosis during the study;
Hormone therapy for endometriosis or the use of aromatase inhibitors within 16 weeks prior to Day 0;

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
Bovhyaluronidase azoximerRectally or vaginally 1 suppository of Longidaze every 2 days. The main course of treatment - 10 suppositories (for 30 days). Then (according to the doctor's decision) supportive therapy is prescribed for 1 suppository 1 time in 7 days. Course of supportive treatment - 17 suppositories for another 120 days. The patients took dienogest according to the instructions for use.	Drug	Longidaze

Primary outcome

Changes in the severity of endometriosis-associated pelvic pain (Day 30)
Time frame: Day 0, Day 30
Changes in the severity of endometriosis-associated pelvic pain by visual analogue scale (VAS) after 30 days from the baseline value in patients of the dienogest + Longidaze® combination therapy group compared with patients who received only dienogest. The Visual Analogue Scale (VAS) is designed to measure pain intensity. It is a continuous scale in the form of a horizontal line 10 cm (100 mm) long and located on it two extreme points: "no pain" and "the strongest pain you can imagine." The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his pain intensity. The ruler measures the distance (mm) between "no pain" and "the worst pain imaginable," providing a score range from 0 to 100. A higher score indicates more pain intensity.

4 secondary outcomes

Changes in the severity of endometriosis-associated pelvic pain (Days 90, 150, 180)
Time frame: Day 0, Day 90, Day 150, Day 180
Change in the Biberoglu and Berman scale
Time frame: Day 0, Day 30, Day 90, Day 150, Day 180
Change in the score on the SF-36 quality of life questionnaire
Time frame: Day 0, Day 30, Day 90, Day 150, Day 180
Change in the severity of uterine bleeding
Time frame: Day 0, Day 30, Day 90, Day 150, Day 180

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of External Genital Endometriosis, run by NPO Petrovax at 6 sites in Russia.

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 7 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 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Russia. 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the severity of endometriosis-associated pelvic pain (Day 30) (time frame: Day 0, Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04962620.

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 22 Jul 2021.