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

Vulvovaginal Atrophy Clinical Trial

— ROSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898556
• Other study ID #: IP-ROSA2020
• Secondary ID: 2020-004517-12
• Status: Recruiting
• Phase: Phase 3
• Start date: December 22, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2021
• Source: Instituto Palacios
• Contact: Dr. Santiago Palacios Palacios, PI
• Phone: +34 91 578 05 17
• Email: ipalacios[@]institutopalacios.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Vulvovaginal Atrophy

Intervention

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:
• Placebo
Patients with a diagnosis of VVA who will not undergo treatment for 12 weeks.

Locations

Country	Name	City	State
Spain	Instituto Palacios	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Santiago Palacios

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Evaluation of vulvo vestibular pain	Through the visual analog scale (VAS)	Screening Visit 1 (Day 0); Visit 2 (Week 4); Visit 3 (Week 12)
Secondary	Evaluation of vulvovaginal vascularization	Through the ECO DOPPLER	Screening visit 1 (Day 0); Visit 3 (Week 12)
Secondary	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)
Secondary	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)