Comparing Safety and Effectiveness of Different Diosmin-Based Venoactive Drugs for Treating Pelvic Venous Disorders in Women Aged 18 to 45

What this Trial Is About

Researchers are evaluating the effectiveness and safety of different venoactive drugs VADs in treating female patients with pelvic venous disorders PeVD, which include conditions like varicose veins in the pelvis and vulva and compression of certain veins. PeVD causes chronic pelvic pain CPP, which greatly affects quality of life, daily activities, and emotional well-being in women. This study aims to compare three diosmin-containing VADs in their ability to relieve CPP and assess patient adherence and side effects. The trial involves 150 women aged 18 to 45 with symptomatic PeVD. Participants are randomly assigned into three groups of 50 each to receive one of the following treatments micronized purified flavonoid fraction MPFF 1000 mg once daily, diosmin 600 mg once daily, or a combination of hesperidin and diosmin 1000 mg once daily. Each treatment lasts for two months, with patients taking their medication every morning during breakfast. Diagnosis and disease characteristics are confirmed using transabdominal and transvaginal duplex ultrasound scans. During the study, participants will record their pelvic pain weekly using a 10-point visual analogue scale VAS. Researchers will monitor pain levels, side effects, and adherence throughout the 8-week treatment. Clinical exams and data collection will occur before and after treatment. Patients are instructed to report any side effects immediately. The main outcome measure is the severity of chronic pelvic pain, assessed weekly. Secondary outcomes include monitoring side effects and adverse events. The study duration for each participant is approximately two months of treatment.

Venoactive Drug Treatment of Pelvic Venous Disorders