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

Perfect Care Distribution

Status: Completed

Conditions: Vaginal Atrophy

Treatments: Device: Halova

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT05654610

HALOVRW/01/2022

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 249 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.