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

NCT04962620 | Unknown

• 1 other identifier: ISLAND
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

External Genital Endometriosis

Keywords

longidaze; external genital endometriosis; bovhyaluronidase azoximer

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0, Day 30

Secondary Outcomes (4)

• Changes in the severity of endometriosis-associated pelvic pain (Days 90, 150, 180)

  Day 0, Day 90, Day 150, Day 180

• Change in the Biberoglu and Berman scale

  Day 0, Day 30, Day 90, Day 150, Day 180

• Change in the score on the SF-36 quality of life questionnaire

  Day 0, Day 30, Day 90, Day 150, Day 180

• Change in the severity of uterine bleeding

  Day 0, Day 30, Day 90, Day 150, Day 180

Study Arms (2)

Longidaze

75 patients receiving combination therapy: Longidaze + dienogest

Drug: Bovhyaluronidase azoximer

Control

74 patients receiving only Dienogest.

Interventions

Bovhyaluronidase azoximer DRUG

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.

Longidaze

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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® )

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• \. Participation in clinical trials less than 30 days before the screening visit and / or 5 drug half-lives, whichever is longer.

Sponsors & Collaborators

• NPO Petrovax: lead

Study Sites (6)

State budgetary healthcare institution "Chelyabinsk Regional Clinical Skin and Venereal Diseases Dispensary"

Chelyabinsk, Chelyabinsk Oblast, 454048, Russia

Location

Federal State Budgetary Scientific Institution "Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott "

Saint Petersburg, Leningradskaya Oblast', 199034, Russia

Location

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, Russia

Location

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, Russia

Location

Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia"

Moscow, 109388, Russia

Location

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, Russia

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 15, 2021
• Study Start: December 26, 2019
• Primary Completion: May 14, 2021
• Study Completion: August 1, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (6)