Actively Recruiting

Phase 3
Age: 18Years - 45Years
FEMALE
NCT06584799

Venoactive Drug Treatment of Pelvic Venous Disorders

Led by Pirogov Russian National Research Medical University · Updated on 2024-12-27

150

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 lack of any data on the comparative efficacy and safety of VADs in the treatment of patients with PeVD. This, in turn, makes not possible for doctors and patients to choose the optimal and most effective drug based on the objective research data. All the above has predetermined the purpose of the planned study as evaluating the efficacy and safety of different VADs in the treatment of female patients with PeVD.

CONDITIONS

Official Title

Venoactive Drug Treatment of Pelvic Venous Disorders

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age from 18 to 45 years
  • Presence of Pelvic Venous Disorder symptoms such as chronic pelvic pain, pain during intercourse, discomfort in the lower abdomen, painful urination, or vulvar varicose veins
  • Presence of pelvic varicose veins with reflux confirmed by duplex ultrasound
  • Pelvic venous reflux lasting longer than 1 second as confirmed by ultrasound
  • Isolated dilation and reflux in the parametrial and uterine veins confirmed by ultrasound
  • No other diseases causing chronic pelvic pain
Not Eligible

You will not qualify if you...

  • No symptoms of the disease (asymptomatic form)
  • Menopause
  • Pregnancy
  • Post-thrombotic disease
  • Tumors
  • Other diseases causing chronic pelvic pain
  • Known allergy to any component of the venoactive drugs used in the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Pirogov Russian National Research Medical University

Moskva, Russia, 117513

Actively Recruiting

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Research Team

S

Sergey G Gavrilov, MD, PhD

CONTACT

A

Alexander V Alenichev

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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