Pilot Clinical Trial of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy

Procare Health

Status

Completed

Conditions

Vulvovaginal Atrophy

Treatments

Device: Idracare

Study type

Interventional

Funder types

Industry

Identifiers

NCT04766957

IDRA

Details and patient eligibility

About

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.

Full description

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.

Enrollment

134 patients

Sex

Female

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.