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:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT04898556
Eligibility Criteria:
Inclusion Criteria:
* Women over 45 years of age with at least one year of amenorrhea and at least one symptom of vulvovaginal atrophy of moderate and / or severe intensity.
* Women with moderate to severe vulvar / vestibular pain
* Women without symptoms or signs of acute vaginal infection.
* Women without symptoms of urinary infection and a negative urine strip result.
* Woman willing to carry out the study procedures and comply with the visits.
* Woman who signs the Informed Consent.
Exclusion Criteria:
* Hormone treatment in the last three months for vulvovaginal atrophy
* Treatment with vaginal moisturizers in the last week for vulvovaginal atrophy
* Laser treatment in the last 6 months.
* Acute and recurrent urinary tract infections in the last 3 months.
* Acute genital infections (herpes, candida, etc)
* Personal history of cancer at any level
* Present alterations in the area to be treated, such as lacerations, abrasions or ulcers (resolution time at the medical discretion)
* Decompensated non-communicable chronic diseases (Diabetes Mellitus, Heart Disease ...)
* Participation in a clinical study 3 months before inclusion or during this study.
* Hypersensitivity to the active principle or any of the excipients
* Undiagnosed vaginal bleeding.
* Untreated endometrial hyperplasia
* Acute liver disease or a history of liver disease while liver function tests remain impaired.
* Current diagnosis or history of venous thromboembolism (deep vein thrombosis, pulmonary embolism)
* Known thrombophilic disorders (protein C, protein S, or antithrombin deficiency)
* Current or recent diagnosis of arterial thromboembolic disease (angina, myocardial infarction)
* Porphyria
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Study:
NCT04898556
Study Brief:
Protocol Section:
NCT04898556