Treatment of pelvic venous disorders with venoactive drugs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of diosmin-containing venoactive drugs (VADs) in relieving chronic pelvic pain (CPP) in female patients with pelvic venous disorders (PeVD). A total of 150 women aged 18 to 45 with symptomatic PeVD will be enrolled, and their CPP severity will be assessed using a visual analogue scale before and weekly during the 2-month treatment period. The study will also compare the effectiveness and safety of different diosmin formulations and monitor patient adherence to the treatment. Diagnostic methods include transabdominal and transvaginal duplex ultrasound to confirm the presence of pelvic varicose veins.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pirogov Russian National Research Medical University
  Moskva, Russia Recruiting

Study contacts

• Study coordinator: Sergey G Gavrilov, MD, PhD
• Email: gavriloffsg@mail.ru
• Phone: 89169299947

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.