Status:
RECRUITING
Venoactive Drug Treatment of Pelvic Venous Disorders
Lead Sponsor:
Pirogov Russian National Research Medical University
Conditions:
Pelvic Venous Disorders
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
Venoactive drug (VAD) therapy is one of the most effective methods of treating chronic venous diseases (CVD). Numerous studies have proven its high efficacy in relieving symptoms of CVD, such as leg p...
Detailed Description
Study objectives: * To evaluate the efficacy of diosmin-containing VADs in the CPP relief in female patients with PeVD; * To evaluate the safety (by the number of side effects and adverse events) of ...
Eligibility Criteria
Inclusion
- Age from 18 to 45 years;
- The presence of PeVD symptoms (CPP, dyspareunia, discomfort in the hypogastrium, dysuria, vulvar varicose veins);
- The presence of pelvic varicose veins with reflux in them, according to DUS;
- Pelvic venous reflux (PVR) lasting for greater than 1 s, according to DUS;
- Isolated dilation and reflux in the parametrial and uterine veins, according to DUS;
- Absence of competing abnormalities, accompanied by CPP.
Exclusion
- Asymptomatic form of the disease;
- Menopause;
- Pregnancy;
- Post-thrombotic disease;
- Neoplasms;
- Competing diseases with CPP;
- Known hypersensitivity to any of the components of the used VAD.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06584799
Start Date
December 1 2024
End Date
February 1 2025
Last Update
December 27 2024
Active Locations (1)
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1
Pirogov Russian National Research Medical University
Moskva, Russia, 117513