Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain
NCT ID: NCT04898556
Last Updated: 2021-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2020-12-22
2021-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Active Treatment
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.
Prasterone 6.5 MG
The dose to be applied will be one Intrarosa ovule (Prasterone 6.5mg) a day before going to bed for 12 weeks.
Control Group
Patients who will not undergo any treatment for vulvovaginal atrophy for 12 weeks.
Placebo
Patients with a diagnosis of VVA who will not undergo treatment for 12 weeks.
Interventions
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Prasterone 6.5 MG
The dose to be applied will be one Intrarosa ovule (Prasterone 6.5mg) a day before going to bed for 12 weeks.
Placebo
Patients with a diagnosis of VVA who will not undergo treatment for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
FEMALE
Yes
Sponsors
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Dr. Santiago Palacios
OTHER
Responsible Party
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Dr. Santiago Palacios
Investigador Principal
Locations
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Instituto Palacios
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-004517-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IP-ROSA2020
Identifier Type: -
Identifier Source: org_study_id
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