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

NCT05654610 | Completed

• 1 other identifier: HALOVRW/01/2022
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 14

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.

Conditions

Vaginal Atrophy

Keywords

Dyspareunia; Dysuria; Vaginal lubrication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical Performance

  30 days

• Patient Satisfaction

  30 days

Interventions

Halova DEVICE

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 Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Halova is a medical device intended for intravaginal administration.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subjects with vulvar or cervical cancer.

Sponsors & Collaborators

• Perfect Care Distribution: lead
• MDX Research: collaborator

Study Sites (14)

Spitalul Clinic Dr. Ion Cantacuzino Bucharest

Bucharest, Romania

Location

Med Life Humanitas Cluj-Napoca

Cluj-Napoca, Romania

Location

Cabinet Medical - Dr. Saleh K. Majed

Craiova, Romania

Location

Cabinet Medical - Dr. Surpanelu Oana

Iași, Romania

Location

MediBlue

Iași, Romania

Location

Clinica Natisan Pitesti

Piteşti, Romania

Location

Cabinet Dr. Rădulescu G. Mihaela Elena

Râmnicu Vâlcea, Romania

Location

Ramnicu Valcea

Râmnicu Vâlcea, Romania

Location

Cabinet Ginecologic Dr. Popescu Sibiu

Sibiu, Romania

Location

Clinica iMED

Sibiu, Romania

Location

Pan Medical Sibiu

Sibiu, Romania

Location

Bradmed SRL

Târgu Jiu, Romania

Location

Clinica Medicala Dr. Cioata Ionel Trifon

Timișoara, Romania

Location

Spitalul Judetean de Urgenta Tulcea

Tulcea, Romania

Location

MeSH Terms

Conditions

Dyspareunia; Dysuria

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ema Peta

  Perfect Care Distribution

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 16, 2022
• Study Start: March 1, 2022
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

RO (14)