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

Completed

• Conditions: Vaginal Atrophy

• Registration Number: NCT05654610
• Lead Sponsor: Perfect Care Distribution

Brief 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).

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Study First Submitted: 2022-11-18
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 249

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rating and assessing of treatment-related Adverse Events	30 days	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

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	30 days	The degree of satisfaction when using the medical device will be assessed using a five-point Likert Scale from Very satisfied to Very unsatisfied
Clinical Performance	30 days	Evaluation by the Investigator of the disorder-related symptoms

Trial Locations

Locations (14)

Cabinet Medical - Dr. Surpanelu Oana; 🇷🇴 Iaşi, Romania

Spitalul Clinic Dr. Ion Cantacuzino Bucharest; 🇷🇴 Bucharest, Romania

MediBlue; 🇷🇴 Iaşi, Romania

Spitalul Judetean de Urgenta Tulcea; 🇷🇴 Tulcea, Romania

Cabinet Ginecologic Dr. Popescu Sibiu; 🇷🇴 Sibiu, Romania

Clinica Medicala Dr. Cioata Ionel Trifon; 🇷🇴 Timişoara, Romania

Med Life Humanitas Cluj-Napoca; 🇷🇴 Cluj-Napoca, Romania

Pan Medical Sibiu; 🇷🇴 Sibiu, Romania

Bradmed SRL; 🇷🇴 Târgu Jiu, Romania

Cabinet Medical - Dr. Saleh K. Majed; 🇷🇴 Craiova, Romania

Clinica Natisan Pitesti; 🇷🇴 Piteşti, Romania

Cabinet Dr. Rădulescu G. Mihaela Elena; 🇷🇴 Râmnicu Vâlcea, Romania

Ramnicu Valcea; 🇷🇴 Râmnicu Vâlcea, Romania

Clinica iMED; 🇷🇴 Sibiu, Romania