Vaginal Atrophy
Conditions
Keywords
Dyspareunia, Dysuria, Vaginal lubrication
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).
Interventions
DEVICEHalova
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
MDX Research
Perfect Care Distribution
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance | 30 days | Evaluation by the Investigator of the disorder-related symptoms |
| 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 |
Countries
Romania
Outcome results
None listed