Clinical trial NCT04898556: Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain
Official title: Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Vulvovaginal Atrophy
Keywords: Vultar/vestibular pain
Dyspareunia
Vaginal dryness
Lead sponsor: Instituto Palacios
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, prospective, open, randomized and controlled clinical study
Primary purpose: TREATMENT

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 / 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: 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.

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

Primary outcomes:
measure: Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy
timeFrame: Screening Visit 1 (Day 0)
measure: Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy
timeFrame: Visit 2 (Week 4)
measure: Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy
timeFrame: Visit 3 (Week 12)
Secondary outcomes:
measure: Evaluation of vulvo vestibular pain
timeFrame: Screening Visit 1 (Day 0); Visit 2 (Week 4); Visit 3 (Week 12)
measure: Evaluation of vulvovaginal vascularization
timeFrame: Screening visit 1 (Day 0); Visit 3 (Week 12)
measure: Evaluation of Ph and cytological maturity index
timeFrame: Screening Visit 1 (Day 0); Visit 3 (Week 12)
measure: Evaluation of the clinical index of vulvar and vaginal health
timeFrame: Screening Visit 1 (Day 0); Visit 3 (Week 12)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Palacios
Study officials:
References: