Real-world Evidence Study on the Performance and Safety of Halova Ovules
NCT ID: NCT05654610
Last Updated: 2023-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
249 participants
OBSERVATIONAL
2022-03-01
2022-07-31
Brief Summary
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Detailed Description
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The secondary objective of this clinical investigation are to evaluate the performance of the medical device by clinical examination, and the degree of patient satisfaction related to the intended use (Likert scale).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Halova
Halova is a class I medical device formulated as vaginal ovules and intended for intravaginal administration in order to promote and/or accelerate the hydration, healing, re-epithelialization and/or soothing of injured, atrophic or irritated vaginal mucosa. The ovules melt evenly in the vaginal mucosa forming a cream with a moisturizing and calming effect that support the restoration of the vaginal epithelium.
Eligibility Criteria
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Inclusion Criteria
* Adult women with atrophic vaginitis caused by estrogen hormone deficiency;
* Adult women who have vaginal dryness as a result of contraceptive treatment or other disorders;
* Subjects with a normal cervical cytology report, e.g. Negative for intraepithelial lesions or malignancy (NILM) or slightly changed to atypical squamous cells of undetermined significance (ASC-US) in the last 6 months;
* Subjects willing to provide signed informed consent for participation in clinical investigation.
Exclusion Criteria
18 Years
65 Years
FEMALE
No
Sponsors
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MDX Research
NETWORK
Perfect Care Distribution
INDUSTRY
Responsible Party
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Principal Investigators
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Ema Peta
Role: STUDY_DIRECTOR
Perfect Care Distribution
Locations
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Spitalul Clinic Dr. Ion Cantacuzino Bucharest
Bucharest, , Romania
Med Life Humanitas Cluj-Napoca
Cluj-Napoca, , Romania
Cabinet Medical - Dr. Saleh K. Majed
Craiova, , Romania
Cabinet Medical - Dr. Surpanelu Oana
Iași, , Romania
MediBlue
Iași, , Romania
Clinica Natisan Pitesti
Piteşti, , Romania
Cabinet Dr. Rădulescu G. Mihaela Elena
Râmnicu Vâlcea, , Romania
Ramnicu Valcea
Râmnicu Vâlcea, , Romania
Cabinet Ginecologic Dr. Popescu Sibiu
Sibiu, , Romania
Clinica iMED
Sibiu, , Romania
Pan Medical Sibiu
Sibiu, , Romania
Bradmed SRL
Târgu Jiu, , Romania
Clinica Medicala Dr. Cioata Ionel Trifon
Timișoara, , Romania
Spitalul Judetean de Urgenta Tulcea
Tulcea, , Romania
Countries
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Other Identifiers
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HALOVRW/01/2022
Identifier Type: -
Identifier Source: org_study_id
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