Real-world Evidence Study on the Performance and Safety of Halova Ovules
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult women, aged between 18 and above, in pre-menopause or menopause;
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Adult women with atrophic vaginitis caused by estrogen hormone deficiency;
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Adult women who have vaginal dryness as a result of contraceptive treatment or other disorders;
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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;
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Subjects willing to provide signed informed consent for participation in clinical investigation.
Exclusion Criteria:
- Subjects with vulvar or cervical cancer.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Spitalul Clinic Dr. Ion Cantacuzino Bucharest | Bucharest | Romania | ||
| 2 | Med Life Humanitas Cluj-Napoca | Cluj-Napoca | Romania | ||
| 3 | Cabinet Medical - Dr. Saleh K. Majed | Craiova | Romania | ||
| 4 | Cabinet Medical - Dr. Surpanelu Oana | Iaşi | Romania | ||
| 5 | MediBlue | Iaşi | Romania | ||
| 6 | Clinica Natisan Pitesti | Piteşti | Romania | ||
| 7 | Cabinet Dr. Rădulescu G. Mihaela Elena | Râmnicu Vâlcea | Romania | ||
| 8 | Ramnicu Valcea | Râmnicu Vâlcea | Romania | ||
| 9 | Cabinet Ginecologic Dr. Popescu Sibiu | Sibiu | Romania | ||
| 10 | Clinica iMED | Sibiu | Romania | ||
| 11 | Pan Medical Sibiu | Sibiu | Romania | ||
| 12 | Clinica Medicala Dr. Cioata Ionel Trifon | Timişoara | Romania | ||
| 13 | Spitalul Judetean de Urgenta Tulcea | Tulcea | Romania | ||
| 14 | Bradmed SRL | Târgu Jiu | Romania |
Sponsors and Collaborators
- Perfect Care Distribution
- MDX Research
Investigators
- Study Director: Ema Peta, Perfect Care Distribution
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HALOVRW/01/2022