Clinical trial NCT04766957: Pilot Clinical Trial of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy
Official title: Pilot Clinical Trial on the Efficacy and Safety of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvovaginal Atrophy
Lead sponsor: Procare Health Iberia S.L.
Sponsor class: INDUSTRY
First posted: 2021-02-23
Enrollment: 134
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open study, only one arm
Primary purpose: TREATMENT

Brief summary: Pilot clinical trial on the efficacy and safety of IDRACARE® in moderate to severe symptoms of vulvovaginal atrophy. To assess the efficacy and safety of Idracare® in the treatment of symptoms of AVV (dryness and / or dyspareunia) associated with menopause.

Detailed description: Pilot clinical trial on the efficacy and safety of IDRACARE® in moderate to severe symptoms of vulvovaginal atrophy. To assess the efficacy and safety of Idracare® in the treatment of symptoms of AVV (dryness and / or dyspareunia) associated with menopause.

Open study with only one arm. The study has a total duration per patient of 3 months: initial visit (V1), a follow-up visit (V2) after 4 weeks of treatment and a final visit (V3) after 12 weeks of treatment.

Eligibility criteria: Inclusion Criteria:

* Women who attend medical centers, either for a visit related to vulvovaginal atrophy (VVA) or for any other reason for consultation, with symptoms of VVA (dryness and / or dyspareunia) of moderate or severe intensity (score 2-3 on the Likert scale).
* Women between the ages of 40 and 65, inclusive, in the peri- or postmenopausal period.
* Women are able to understand and sign the informed consent after the nature of the study has been fully explained to them.

Exclusion Criteria:

* Pregnant or immediate postpartum patients (up to 40 days).
* Formal contraindication for the use of the product, such as hypersensitivity to any of the components of the study treatment.
* Use of any other experimental drug or device during the 30 days prior to screening.
* Use of topical antibiotics or antifungals applied vaginally in the two weeks prior to the initial visit.
* Use of contraceptives for vaginal application.
* Decompensated chronic diseases (diabetes, epilepsy, high blood pressure, etc.)
* Undiagnosed abnormal genital bleeding or presence of vaginal lesion.
* Active genitourinary infections at the time of inclusion or in the 15 days prior to inclusion in the study.
* Impossibility, at the discretion of the researcher, to comply with the requirements of the study, either due to follow-up problems, or due to their psychophysical characteristics.

Primary outcomes:
measure: Efficacy of Idracare® in the treatment of symptoms of vulvovaginal atrophy (VVA)
timeFrame: Through study completion, an average of 12 weeks
measure: Safety of Idracare® in the treatment of symptoms of vulvovaginal atrophy (VVA) measuring the incidence, nature and severity of adverse events (AE).
timeFrame: Through study completion, an average of 12 weeks
Secondary outcomes:
measure: To evaluate the effect of Idracare® gel using Bachmann Vaginal Health Index (BVHI).
timeFrame: 4 and 12 weeks
measure: To evaluate the effect of Idracare® gel using vulvar health index (VHI).
timeFrame: 4 and 12 weeks
measure: To evaluate the effect of Idracare® gel using vaginal pH
timeFrame: 4 and 12 weeks
measure: To evaluate the effect of Idracare® gel using maturation of vaginal epithelial cells.
timeFrame: 4 and 12 weeks
measure: To evaluate the effect of Idracare® gel using vaginal microbiota.
timeFrame: 4 and 12 weeks
measure: The degree of satisfaction with the use of Idracare®
timeFrame: 4 and 12 weeks
measure: The tolerability of the treatment using a 5-point Likert-type scale
timeFrame: 4 and 12 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Clínica Sagrada Familia
city: Madrid
country: Spain
facility: HM Gabinete Velázquez
city: Madrid
country: Spain
facility: Instituto Palacios de Salud y Medicina de la Mujer
city: Zaragoza
country: Spain
facility: HU Miguel Servet
Study officials:
affiliation: Procare health Iberia
name: Josep Combalia, MD
role: STUDY_DIRECTOR
affiliation: Clínica Sagrada Familia
name: Fernando Losa, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Palacios de Salud y Medicina de la Mujer
name: Santiago Palacios, Doctor
role: PRINCIPAL_INVESTIGATOR
References: