Venoactive Drug Treatment for Pelvic Venous Disorders
Venoactive Drug Treatment of Pelvic Venous Disorders
Recruiting
Phase 3Interventional Study
Pelvic Venous Disorders
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 45
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Pirogov Russian National Research Medical University · Other
Who this trial is looking for
This trial is looking for women aged 18 to 45 with pelvic venous disorders. Participants will take a venoactive drug to help relieve symptoms such as chronic pelvic pain.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 45 years old.
I have chronic pelvic pain.
I have discomfort in the lower abdomen.
I have pelvic varicose veins.
I have pelvic venous reflux lasting more than 1 second.
I have isolated dilation and reflux in my parametrial and uterine veins.
I do not have other conditions causing pelvic pain.
You may not be able to join if
I do not have any symptoms of pelvic venous disorders.
I am menopausal.
I am pregnant.
I have post-thrombotic disease.
I have any tumors.
I have other conditions that cause pelvic pain.
I am allergic to any components of the venoactive drug.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
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Eligibility Criteria
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…
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.
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