NCT04962620

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 149 (estimated)
• Sponsor: NPO Petrovax · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• External Genital Endometriosis

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2019-12-26
• Primary completion: 2021-05-14
• Completion: 2021-08-01
• First posted: 2021-07-15
• Last updated: 2021-07-22

Locations

6 sites across 1 country: Russia