Status:
UNKNOWN
Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain
Lead Sponsor:
Dr. Santiago Palacios
Conditions:
Vulvovaginal Atrophy
Eligibility:
FEMALE
45+ years
Phase:
PHASE3
Brief Summary
A prospective, open, randomized and controlled clinical intervention study in women over 45 years of age with a diagnosis of vulvovaginal atrophy (dryness and / or dyspareunia, etc.) and vulvar and / ...
Detailed Description
A sample of 50 women over 45 years of age with at least one year of amenorrhea and who require treatment for vulvovaginal atrophy of moderate and / or severe intensity and who present vulvar and vagin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04898556
Start Date
December 22 2020
End Date
June 30 2021
Last Update
June 2 2021
Active Locations (1)
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1
Instituto Palacios
Madrid, Spain, 28009