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

NCT05654610 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 249

Last updated 2023-04-19

No results posted yet for this study

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.

Conditions

  • Vaginal Atrophy

Interventions

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.

Sponsors & Collaborators

  • MDX Research

    collaborator NETWORK

  • Perfect Care Distribution

    lead INDUSTRY

Principal Investigators

  • Ema Peta · Perfect Care Distribution

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05654610 on ClinicalTrials.gov