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

Perfect Care Distribution249 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

249

Conditions

Vaginal Atrophy

Interventions

HalovaDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (14)

Spitalul Clinic Dr. Ion Cantacuzino Bucharest

Bucharest, Romania

Med Life Humanitas Cluj-Napoca

Cluj-Napoca, Romania

Cabinet Medical - Dr. Saleh K. Majed

Craiova, Romania

Outcomes

Primary Outcomes

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

Time frame: 30 days

Secondary Outcomes

Clinical Performance

Evaluation by the Investigator of the disorder-related symptoms

Time frame: 30 days

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

Time frame: 30 days

Data from ClinicalTrials.gov

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