Study of the Efficacy and Safety of Longidaze® for the Treatment of Patients With External Genital Endometriosis
NCT ID: NCT04962620
Last Updated: 2021-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
149 participants
OBSERVATIONAL
2019-12-26
2021-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis
NCT03481842
Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients
NCT02894151
Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain
NCT04372121
Subcutaneous Progesterone Supplementation in Patients With Endometriosis
NCT02793908
Letrozole in the Treatment of Severe and Recurrent Endometriosis
NCT00240942
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Longidaze
75 patients receiving combination therapy: Longidaze + dienogest
Bovhyaluronidase azoximer
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.
Control
74 patients receiving only Dienogest.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bovhyaluronidase azoximer
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients over 18 years of age with active menstrual function;
3. Women with external genital endometriosis, confirmed morphologically and visually during laparoscopic or laparotomy surgery performed 10 years to 2 weeks prior to Day 0;
4. 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;
5. Willingness to use barrier methods of contraception.
Exclusion Criteria
2. Adenomyosis;
3. Amenorrhea (more than 3 months in a row within 6 months before screening);
4. Patients who are scheduled to undergo surgery for endometriosis during the study;
5. Hormone therapy for endometriosis or the use of aromatase inhibitors within 16 weeks prior to Day 0;
6. 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.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NPO Petrovax
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
State budgetary healthcare institution "Chelyabinsk Regional Clinical Skin and Venereal Diseases Dispensary"
Chelyabinsk, Chelyabinsk Oblast, Russia
Federal State Budgetary Scientific Institution "Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott "
Saint Petersburg, Leningradskaya Oblast', Russia
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, Russia
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, Russia
Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia"
Moscow, , Russia
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, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ISLAND
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.