Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain

Inclusion Criteria:

• Women over 45 years of age with at least one year of amenorrhea and at least onesymptom 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 orulcers (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 remainimpaired.
• 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, myocardialinfarction)
• Porphyria