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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Vaginal Atrophy

Intervention / Treatment
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* Device: Halova


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Performance | Evaluation by the Investigator of the disorder-related symptoms | 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 | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyspareunia, Dysuria, Vaginal lubrication