Back to resultsClinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain (ROSA)
Primary Purpose
Vulvovaginal Atrophy
Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Prasterone 6.5 MG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vulvovaginal Atrophy focused on measuring Vultar/vestibular pain, Dyspareunia, Vaginal dryness
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
Sites / Locations
- Instituto PalaciosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active Treatment
Control Group
Arm Description
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.
Patients who will not undergo any treatment for vulvovaginal atrophy for 12 weeks.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Evaluation of vulvo vestibular pain
Through the visual analog scale (VAS)
Evaluation of vulvovaginal vascularization
Through the ECO DOPPLER
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.
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 ...
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04898556
Brief Title
Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain
Acronym
ROSA
Official Title
Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Santiago Palacios
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy
Keywords
Vultar/vestibular pain, Dyspareunia, Vaginal dryness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Interventional, prospective, open, randomized and controlled clinical study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Patients who will not undergo any treatment for vulvovaginal atrophy for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Prasterone 6.5 MG
Other Intervention Name(s)
Active Treatment
Intervention Description
The dose to be applied will be one Intrarosa ovule (Prasterone 6.5mg) a day before going to bed for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control Group
Intervention Description
Patients with a diagnosis of VVA who will not undergo treatment for 12 weeks.
Primary Outcome Measure Information:
Title
Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy
Description
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)
Title
Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy
Description
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)
Title
Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy
Description
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)
Secondary Outcome Measure Information:
Title
Evaluation of vulvo vestibular pain
Description
Through the visual analog scale (VAS)
Time Frame
Screening Visit 1 (Day 0); Visit 2 (Week 4); Visit 3 (Week 12)
Title
Evaluation of vulvovaginal vascularization
Description
Through the ECO DOPPLER
Time Frame
Screening visit 1 (Day 0); Visit 3 (Week 12)
Title
Evaluation of Ph and cytological maturity index
Description
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)
Title
Evaluation of the clinical index of vulvar and vaginal health
Description
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Santiago Palacios Palacios, PI
Phone
+34 91 578 05 17
Email
ipalacios@institutopalacios.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dra. Marieta Ramirez, SI
Phone
+34 91 578 05 17
Email
investigacion@institutopalacios.com
Facility Information:
Facility Name
Instituto Palacios
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santiago Palacios, PI
Phone
+34 91 578 05 17
Email
investigacion@institutopalacios.com
First Name & Middle Initial & Last Name & Degree
Marieta Ramirez, SI
Phone
+34 91 578 05 17
Email
investigacion@institutopalacios.com
First Name & Middle Initial & Last Name & Degree
Dr. Santiago Palacios, PI
First Name & Middle Initial & Last Name & Degree
Dra. Marieta Ramirez, SI
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain
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