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

Launched by PERFECT CARE DISTRIBUTION · Dec 8, 2022

Keywords

ClinConnect Summary

The primary objective of this investigation is to evaluate the therapeutic performance and tolerability of Halova ovules in treating vaginal atrophy and restoring the natural lubrication of the vaginal mucosa.

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).

Gender

FEMALE

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.

Trial Officials