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Completed

NCT Number: NCT05654610

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Spitalul Clinic Dr. Ion Cantacuzino Bucharest, Bucharest, Romania

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Rating and assessing of treatment-related Adverse Events

    Time frame: 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 outcomes

  1. Clinical Performance

    Time frame: 30 days

    Evaluation by the Investigator of the disorder-related symptoms

  2. Patient Satisfaction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Perfect Care Distribution

Industry

Collaborators

  • MDX Research

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2022
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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