Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain (ROSA)

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.

Study Overview

• Status: Recruiting
• Conditions: Vulvovaginal Atrophy
• Intervention / Treatment: Drug: Prasterone 6.5 MG; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dr. Santiago Palacios Palacios, PI; Phone Number: +34 91 578 05 17; Email: ipalacios@institutopalacios.com
• Study Contact Backup: Name: Dra. Marieta Ramirez, SI; Phone Number: +34 91 578 05 17; Email: investigacion@institutopalacios.com

Study Locations

• Spain
  • Madrid, Spain, 28009
    • Recruiting
    • Instituto Palacios
    • Contact: Santiago Palacios, PI; Phone Number: +34 91 578 05 17; Email: investigacion@institutopalacios.com
    • Contact: Marieta Ramirez, SI; Phone Number: +34 91 578 05 17; Email: investigacion@institutopalacios.com
    • Principal Investigator: Dr. Santiago Palacios, PI
    • Sub-Investigator: Dra. Marieta Ramirez, SI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.; Other Names: Active Treatment
Placebo Comparator: Control Group; Patients who will not undergo any treatment for vulvovaginal atrophy for 12 weeks.	Other: Placebo; Patients with a diagnosis of VVA who will not undergo treatment for 12 weeks.; Other Names: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of vulvo vestibular pain	Through the visual analog scale (VAS)	Screening Visit 1 (Day 0); Visit 2 (Week 4); Visit 3 (Week 12)
Evaluation of vulvovaginal vascularization	Through the ECO DOPPLER	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.	Screening Visit 1 (Day 0); Visit 3 (Week 12)
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 ...	Screening Visit 1 (Day 0); Visit 3 (Week 12)

Collaborators and Investigators

• Sponsor: Dr. Santiago Palacios

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Actual): May 1, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Dyspareunia; Vaginal dryness; Vultar/vestibular pain
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Dehydroepiandrosterone
• Other Study ID Numbers: IP-ROSA2020; 2020-004517-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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