Status:
COMPLETED
Pilot Clinical Trial of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy
Lead Sponsor:
Procare Health Iberia S.L.
Conditions:
Vulvovaginal Atrophy
Eligibility:
FEMALE
40-65 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2022
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT04766957
Start Date
October 26 2020
End Date
December 2 2022
Last Update
January 27 2023
Active Locations (4)
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1
Clínica Sagrada Familia
Barcelona, Spain, 08022
2
HM Gabinete Velázquez
Madrid, Spain, 28001
3
Instituto Palacios de Salud y Medicina de la Mujer
Madrid, Spain, 28009
4
HU Miguel Servet
Zaragoza, Spain, 50009