Clinical trial NCT04962620: Study of the Efficacy and Safety of Longidaze® for the Treatment of Patients With External Genital Endometriosis
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: External Genital Endometriosis
Keywords: longidaze
external genital endometriosis
bovhyaluronidase azoximer
Lead sponsor: NPO Petrovax
Sponsor class: INDUSTRY
First posted: 2021-07-15
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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® )

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

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.

Eligibility criteria: Inclusion Criteria:

1. Documented informed consent;
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:

1. Women before menarche or after menopause
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.

Primary outcomes:
measure: Changes in the severity of endometriosis-associated pelvic pain (Day 30)
timeFrame: Day 0, Day 30
Secondary outcomes:
measure: Changes in the severity of endometriosis-associated pelvic pain (Days 90, 150, 180)
timeFrame: Day 0, Day 90, Day 150, Day 180
measure: Change in the Biberoglu and Berman scale
timeFrame: Day 0, Day 30, Day 90, Day 150, Day 180
measure: Change in the score on the SF-36 quality of life questionnaire
timeFrame: Day 0, Day 30, Day 90, Day 150, Day 180
measure: Change in the severity of uterine bleeding
timeFrame: Day 0, Day 30, Day 90, Day 150, Day 180
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: State budgetary healthcare institution "Chelyabinsk Regional Clinical Skin and Venereal Diseases Dispensary"
state: Chelyabinsk Region
city: Saint Petersburg
country: Russian Federation
facility: Federal State Budgetary Scientific Institution "Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott "
state: Leningrad Region
city: Nizhny Novgorod
country: Russian Federation
facility: Private health care institution "Road clinical hospital at the station Nizhny Novgorod of the open joint stock company" Russian Railways "
state: Nizhny Novgorod Region
city: Voronezh
country: Russian Federation
facility: 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
state: Voronezh Region
city: Moscow
country: Russian Federation
facility: Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia"
city: Moscow
country: Russian Federation
facility: 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
Study officials:
References: