Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT04962620
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04962620
Study Brief:
Protocol Section:
NCT04962620