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

Vaginal Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05654610
• Other study ID #: HALOVRW/01/2022
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: July 31, 2022

Study information

• Verified date: April 2023
• Source: Perfect Care Distribution
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Vaginal Atrophy

Intervention

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.

Locations

Country	Name	City	State
Romania	Spitalul Clinic Dr. Ion Cantacuzino Bucharest	Bucharest
Romania	Med Life Humanitas Cluj-Napoca	Cluj-Napoca
Romania	Cabinet Medical - Dr. Saleh K. Majed	Craiova
Romania	Cabinet Medical - Dr. Surpanelu Oana	Iasi
Romania	MediBlue	Iasi
Romania	Clinica Natisan Pitesti	Pitesti
Romania	Cabinet Dr. Radulescu G. Mihaela Elena	Râmnicu Vâlcea
Romania	Ramnicu Valcea	Râmnicu Vâlcea
Romania	Cabinet Ginecologic Dr. Popescu Sibiu	Sibiu
Romania	Clinica iMED	Sibiu
Romania	Pan Medical Sibiu	Sibiu
Romania	Bradmed SRL	Târgu Jiu
Romania	Clinica Medicala Dr. Cioata Ionel Trifon	Timisoara
Romania	Spitalul Judetean de Urgenta Tulcea	Tulcea

Sponsors (2)

Lead Sponsor	Collaborator
Perfect Care Distribution	MDX Research

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating and assessing of treatment-related Adverse Events	The safety of Halova® ovules as measured by the rate of treatment-related adverse events, including serious adverse events (SAEs), in subjects participating in the clinical investigation	30 days
Secondary	Clinical Performance	Evaluation by the Investigator of the disorder-related symptoms	30 days
Secondary	Patient Satisfaction	The degree of satisfaction when using the medical device will be assessed using a five-point Likert Scale from Very satisfied to Very unsatisfied	30 days