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Venoactive Drug Treatment of Pelvic Venous Disorders

RecruitingPhase 3NCT06584799
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 pain and swelling, leg heaviness and fatigue. Pelvic venous disorders (PeVDs) represent a group of pathological conditions including varicose veins of the pelvis and vulva, and compression stenoses of the left renal and common iliac veins. Although PeVDs are associated with venous lesions of the pelvis and retroperitoneum and have specific clinical manifestations, they are one of the forms of CVD and constitute a separate cohort. A number of studies on the VAD usage in PeVD indicate the wide possibilities of this type of treatment in eliminating chronic pelvic pain (CPP), the most dramatic symptom of PeVD, which is the main cause of disability and decreased quality of life, social and daily activity in women with PeVD. Currently, a variety of VADs are presented on the pharmaceutical market, which, according to the product labels, provide effects not only on the venous outflow from the lower extremities, but also on venous hemodynamics in the pelvis. At the same time, a literature analysis shows that micronized purified flavonoid fraction (MPFF) has the greatest evidence base obtained in the efficacy and safety studies of VADs in PeVD. Nevertheless, patients are rarely interested in the scientific dossier of drugs, and in the real practice the patients with PeVD and CPP most often ask: "What is the best drug to use for the CPP relief?" This is quite understandable, as it is CPP in PeVD that results not only in disability, but also in family conflicts, psycho-emotional stress and depressive states. In this regard, patients seek to get rid of pain as soon as possible and strive to use the most effective drug. An extensive scientific base of comparative studies on the use of various VADs in patients with CVD and PeVD has been accumulated to date. However, the literature is l…

Study details

Official title
Comparative Assessment of the Efficacy and Safety of Venoactive Drug Treatment of Pelvic Venous Disorders
Conditions
  • Pelvic Venous Disorders
Interventions
  • Drug: Micronized purified flavonoid fraction
  • Drug: Diosmin 600
  • Drug: Hesperidin+Diosmin combination 1000
Sponsor
Pirogov Russian National Research Medical University
Start date
2024-12
Primary completion
2025-01
Sex
Female
Age range
from 18 Years to 45 Years
Results posted
No results posted in this snapshot
Countries
Russia
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06584799