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

NPO Petrovax

Status: Unknown

Conditions: External Genital Endometriosis

Treatments: Drug: Bovhyaluronidase azoximer

Study type: Observational

Funder types: Industry

Identifiers

NCT04962620

ISLAND

Details and patient eligibility

About

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

Full 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.

Enrollment: 149 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

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

Trial design

149 participants in 2 patient groups

Longidaze

Description:

75 patients receiving combination therapy: Longidaze + dienogest

Treatment:

Drug: Bovhyaluronidase azoximer

Control

Description:

74 patients receiving only Dienogest.