NCT05654610

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

Real-world Evidence Study on the Performance and Safety of the Medical Device Halova Ovules in the Local Treatment of Vaginal Atrophy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 249 (actual)
• Sponsor: Perfect Care Distribution · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Vaginal Atrophy

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2022-12-16
• Last updated: 2023-04-19

Locations

14 sites across 1 country: Romania