Clinical trial NCT05654610: Real-world Evidence Study on the Performance and Safety of Halova Ovules
Official title: Real-world Evidence Study on the Performance and Safety of the Medical Device Halova Ovules in the Local Treatment of Vaginal Atrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Atrophy
Keywords: Dyspareunia
Dysuria
Vaginal lubrication
Lead sponsor: Perfect Care Distribution
Sponsor class: INDUSTRY
Collaborators: name: MDX Research
First posted: 2022-12-16
Enrollment: 249
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult women, with atrophic vaginitis caused by estrogen hormone deficiency or vaginal dryness as a result of contraceptive treatment or other disorders.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Rating and assessing of treatment-related Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: Clinical Performance
timeFrame: 30 days
measure: Patient Satisfaction
timeFrame: 30 days
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Spitalul Clinic Dr. Ion Cantacuzino Bucharest
city: Cluj-Napoca
country: Romania
facility: Med Life Humanitas Cluj-Napoca
city: Craiova
country: Romania
facility: Cabinet Medical - Dr. Saleh K. Majed
city: Iaşi
country: Romania
facility: Cabinet Medical - Dr. Surpanelu Oana
city: Iaşi
country: Romania
facility: MediBlue
city: Piteşti
country: Romania
facility: Clinica Natisan Pitesti
city: Râmnicu Vâlcea
country: Romania
facility: Cabinet Dr. Rădulescu G. Mihaela Elena
city: Râmnicu Vâlcea
country: Romania
facility: Ramnicu Valcea
city: Sibiu
country: Romania
facility: Cabinet Ginecologic Dr. Popescu Sibiu
city: Sibiu
country: Romania
facility: Clinica iMED
city: Sibiu
country: Romania
facility: Pan Medical Sibiu
city: Timişoara
country: Romania
facility: Clinica Medicala Dr. Cioata Ionel Trifon
city: Tulcea
country: Romania
facility: Spitalul Judetean de Urgenta Tulcea
city: Târgu Jiu
country: Romania
facility: Bradmed SRL
Study officials:
affiliation: Perfect Care Distribution
name: Ema Peta
role: STUDY_DIRECTOR
References: