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

• Status: Recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: Female

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 / or vestibular pain. The efficacy of Prasterone treatment is evaluated in those patients willing to undergo the treatment compared to the control group.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. Santiago Palacios
• Treatments: Dehydroepiandrosterone

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