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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The dose to be applied will be one Intrarosa ovule (Prasterone 6.5mg) a day before going to bed for 12 weeks.
Patients with a diagnosis of VVA who will not undergo treatment for 12 weeks.
Instituto Palacios
Madrid, Spain
RECRUITINGTreatment 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.
Time frame: 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.
Time frame: 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.
Time frame: Visit 3 (Week 12)
Evaluation of vulvo vestibular pain
Through the visual analog scale (VAS)
Time frame: Screening Visit 1 (Day 0); Visit 2 (Week 4); Visit 3 (Week 12)
Evaluation of vulvovaginal vascularization
Through the ECO DOPPLER
Time frame: 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.
Time frame: Screening Visit 1 (Day 0); Visit 3 (Week 12)
Evaluation of the clinical index of vulvar and vaginal health
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It is carried out through a clinical parameter that takes into account humidity, hydration, elasticity, pH among others ...
Time frame: Screening Visit 1 (Day 0); Visit 3 (Week 12)