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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 vaginal pain within these symptoms will be chosen. At the beginning of the study, after passing the selection criteria and signing the informed consent, the patients will be randomly assigned to one of the two arms of the study, (active group) or (control group), said assignment will be made randomly. Through a computer program where one or the other arm of treatment will be assigned to the patient at random to guarantee the homogeneity of both study groups and thus avoid selection biases.

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

Conditions
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Vulvovaginal Atrophy

Intervention / Treatment
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* Drug: Prasterone 6.5 MG
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional, prospective, open, randomized and controlled clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Treatment<br>Patients who will undergo treatment with Intrarosa (Prasterone 6.5mg) in ovules, will apply one ovule a day before going to bed for 12 weeks. | Drug: Prasterone 6.5 MG<br>* The dose to be applied will be one Intrarosa ovule (Prasterone 6.5mg) a day before going to bed for 12 weeks.<br>* Other names: Active Treatment;|
| Placebo Comparator: Control Group<br>Patients who will not undergo any treatment for vulvovaginal atrophy for 12 weeks. | Other: Placebo<br>* Patients with a diagnosis of VVA who will not undergo treatment for 12 weeks.<br>* Other names: Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy | Clinical study to evaluate the efficacy of Prasterone treatment for vulvovaginal atrophy in postmenopausal women with vulvar / vestibular pain. | Screening Visit 1 (Day 0) | 
| Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy | Clinical study to evaluate the efficacy of Prasterone treatment for vulvovaginal atrophy in postmenopausal women with vulvar / vestibular pain. | Visit 2 (Week 4) | 
| Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy | Clinical study to evaluate the efficacy of Prasterone treatment for vulvovaginal atrophy in postmenopausal women with vulvar / vestibular pain. | Visit 3 (Week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of vulvo vestibular pain | Through the visual analog scale (VAS) | Screening Visit 1 (Day 0); Visit 2 (Week 4); Visit 3 (Week 12) | 
| Evaluation of vulvovaginal vascularization | Through the ECO DOPPLER | Screening visit 1 (Day 0); Visit 3 (Week 12) | 
| Evaluation of Ph and cytological maturity index | On the lateral side of the vagina we take the Ph sample through a strip, and the cytological maturity is taken through a swab to take a sample from the cervical area. | Screening Visit 1 (Day 0); Visit 3 (Week 12) | 
| Evaluation of the clinical index of vulvar and vaginal health | It is carried out through a clinical parameter that takes into account humidity, hydration, elasticity, pH among others ... | Screening Visit 1 (Day 0); Visit 3 (Week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vultar/vestibular pain, Dyspareunia, Vaginal dryness