External Genital Endometriosis
Conditions
Keywords
longidaze, external genital endometriosis, bovhyaluronidase azoximer
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.
Interventions
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.
Sponsors
NPO Petrovax
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the severity of endometriosis-associated pelvic pain (Day 30) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the severity of endometriosis-associated pelvic pain (Days 90, 150, 180) | Day 0, Day 90, Day 150, Day 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. |
| Change in the Biberoglu and Berman scale | Day 0, Day 30, Day 90, Day 150, Day 180 | 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. |
| 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 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. |
| Change in the severity of uterine bleeding | Day 0, Day 30, Day 90, Day 150, Day 180 | 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. |
Countries
Russia
Outcome results
None listed