Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain
ROSA
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2020
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 22, 2020
CompletedFirst Submitted
Initial submission to the registry
February 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedFirst Posted
Study publicly available on registry
May 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedJune 2, 2021
May 1, 2021
4 months
February 9, 2021
May 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
Evaluation of vulvo vestibular pain
Screening Visit 1 (Day 0); Visit 2 (Week 4); Visit 3 (Week 12)
Evaluation of vulvovaginal vascularization
Screening visit 1 (Day 0); Visit 3 (Week 12)
Evaluation of Ph and cytological maturity index
Screening Visit 1 (Day 0); Visit 3 (Week 12)
Evaluation of the clinical index of vulvar and vaginal health
Screening Visit 1 (Day 0); Visit 3 (Week 12)
Study Arms (2)
Active Treatment
ACTIVE COMPARATORPatients who will undergo treatment with Intrarosa (Prasterone 6.5mg) in ovules, will apply one ovule a day before going to bed for 12 weeks.
Control Group
PLACEBO COMPARATORPatients who will not undergo any treatment for vulvovaginal atrophy for 12 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 ...)
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Palacios
Madrid, 28009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Investigador Principal
Study Record Dates
First Submitted
February 9, 2021
First Posted
May 24, 2021
Study Start
December 22, 2020
Primary Completion
May 1, 2021
Study Completion
June 30, 2021
Last Updated
June 2, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share