Phlebotonics for venous insufficiency.
Maria José Martinez-Zapata, Robin Wm Vernooij, Daniel Simancas-Racines...
https://pubmed.ncbi.nlm.nih.gov/33141449Actively Recruiting
Phase 3
Age: 18Years - 45Years
FEMALE
ID06584799
Comparing the Effects and Safety of Different Venous Drugs for Pelvic Venous Disorders and Chronic Pelvic Pain in Women
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
Researchers are evaluating the effectiveness and safety of different venoactive drugs (VADs) in treating pelvic venous disorders (PeVD) in women. PeVD includes conditions like varicose veins in the pelvis and vulva and vein compression, often causing chronic pelvic pain (CPP), which significantly affects quality of life. This Phase 3 study focuses on comparing various diosmin-containing VADs to identify the best option for symptom relief in reproductive-aged women with PeVD. The study involves three groups of 50 female patients each, who will receive one of three VAD 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. All treatments will be taken during breakfast for two months. Before and during treatment, patients will undergo pelvic vein ultrasounds and clinical examinations to confirm diagnosis and assess venous reflux. Participants will rate their chronic pelvic pain weekly using a visual analogue scale (VAS) over eight weeks. Safety will be monitored by recording side effects and adverse events. Patients will report any issues immediately to investigators. The study will also evaluate patient adherence to the medications. The main measure is the severity of pelvic pain weekly throughout the treatment period, with follow-up exams at the end of two months.
CONDITIONS
Official Title
Venoactive Drug Treatment of Pelvic Venous Disorders
Who Can Participate
Age: 18Years - 45Years
FEMALE
Eligibility Criteria
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
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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1
2
3
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
A
Alexander V Alenichev
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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Published Research Related To This Trial
Editor's Choice - European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs.
Marianne G De Maeseneer, Stavros K Kakkos, Thomas Aherne...
https://pubmed.ncbi.nlm.nih.gov/35027279Management of chronic venous disorders of the lower limbs. Guidelines According to Scientific Evidence. Part I.
Andrew Nicolaides, Stavros Kakkos, Niels Baekgaard...
https://pubmed.ncbi.nlm.nih.gov/29871479Diagnosis and treatment of pelvic congestion syndrome: UIP consensus document.
Pier-Luigi Antignani, Zaza Lazarashvili, Javier L Monedero...
https://pubmed.ncbi.nlm.nih.gov/31345010Effects of micronized purified flavonoid fraction (Daflon) on pelvic pain in women with laparoscopically diagnosed pelvic congestion syndrome: a randomized crossover trial.
M Simsek, F Burak, O Taskin
https://pubmed.ncbi.nlm.nih.gov/17629162Clinical Efficacy of Conservative Treatment with Micronized Purified Flavonoid Fraction in Female Patients with Pelvic Congestion Syndrome.
Rustem V Akhmetzianov, Roman A Bredikhin
https://pubmed.ncbi.nlm.nih.gov/34537951Effectiveness and safety of micronized purified flavonoid fraction for the treatment of concomitant varicose veins of the pelvis and lower extremities.
Sergey G Gavrilov, Yekaterina P Moskalenko, Anatoly V Karalkin
https://pubmed.ncbi.nlm.nih.gov/30468077Venoactive drug treatment for patients with pelvic varicose veins: Results of the single-center, randomized, open-label study (VENOTREAT).
Sergey G Gavrilov, Yekaterina P Moskalenko, Anastasiya S Grishenkova...
https://pubmed.ncbi.nlm.nih.gov/40855727