Real-world Evidence Study on the Performance and Safety of Halova Ovules (NCT05654610) | Clinical Trial Compass
CompletedNot Applicable
Real-world Evidence Study on the Performance and Safety of Halova Ovules
Romania249 participantsStarted 2022-03-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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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.
What they're measuring
1
Rating and assessing of treatment-related Adverse Events