Real-world Evidence Study on the Performance and Safety of Halova Ovules

Conditions: Vaginal Atrophy

Sex: Female

Ages: 18 Years – N/A

Enrollment: 249

Sponsor: Perfect Care Distribution

Location: Romania

Summary

An open-label, multicentric, non-randomized, single-arm, pilot, interventional clinical investigation to confirm the tolerability and performance of the medical device Halova in lubrication of the vagina and vaginal atrophy treatment.

Eligibility Criteria

Inclusion Criteria:Adult women, aged between 18 and above, in pre-menopause or menopause;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:Subjects with vulvar or cervical cancer.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05654610). StuddyBuddy aggregates publicly available trial information.