Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT02907320
Eligibility Criteria:
Inclusion Criteria:
1. Inclusion criteria
* Non-menopausal women aged from 18 to 50 years
* Symptomatic Primary chronic disorder C2 or C3 of advanced CEAP
* Regular menstrual cycle
* Use an efficient method of contraception
* Having signed her written informed
2. Non-inclusion criteria 2.1 Related to pathology:
* Superficial and or deep venous thrombosis
* Venous insufficiency including history of deep venous thrombosis, post thrombotic syndrome, venous dysplasia, compressive syndrome
* History of venous strapping or phlebotomy/ surgery of the evaluated leg
* Sclerosing injection within 6 month before inclusion
* Oedema from other etiology
* Paresthesia, cramps of the lower limbs from other origin 2.2 Related to treatment:
* Hypersensitivity, allergy or intolerance to study drugs
* Iron storage disorder
* Intake of venotonic treatment (oral or topic) ,triptan ,diuretics ,calcium blockers, beta blockers, ACE inhibitors, angiotensine II inhibitors, vasodilatators and/or vasoconstrictors within 1 month before inclusion
* Intake of NSAID,corticosteroids,ergotamine, dihydroergotamine or any ergot alkaloids,vitamin C nutraceutical or phytotherapy products with potential venotonic effect within 2 weeks before inclusion 2.3 Related to the population:
* History of diabetes
* BMI≥ 30
* Grade V and VI on Fitzpatrick classification
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02907320
Study Brief:
Protocol Section:
NCT02907320