Clinical Investigation To Evaluate Cerviron Ovules® in Symptomatic Vaginitis

NCT04735705 | Completed Results

• 1 other identifier: CYRON/01/2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

CYRON is a Prospective, Open-Label, Pilot, Multicentric Clinical Investigation to Evaluate the Performance and Safety of Cerviron Ovules® in the Local Treatment of Non-Specific or Endogenous, Symptomatic Vaginitis. The primary objective is to assess the therapeutic performance and tolerability of Cerviron® Ovules in patients with symptomatic, non-specific, non-infectious vaginitis, and endogenous symptomatic infections. The secondary objective of this clinical investigation is the assessment of performance of the medical device by several additionally clinical outcomes (vaginal discharge, vaginal pH, microscopic characteristics of inflammatory cells and characteristics of vaginal microflora). Participants will also evaluate the degree of satisfaction related to the use of the medical device.

Conditions

Vaginitis and Vulvovaginitis

Keywords

Vaginitis; vaginal discharge, vaginal pH, vaginal microflora

Outcome Measures

Primary Outcomes (2)

• Number of Participants With the Same Gynaecological Conditions at the End of Treatment Visit

  Success is defined by resolution (return to patient's usual gynaecological conditions, i.e. before the episode which warranted inclusion in the study) OR substantial improvement of clinical signs of infectious vaginitis (i.e. abnormal vaginal discharge), and/or vaginal symptoms (vaginal burning and/or vaginal pain, and/or vaginal irritation and/or pruritus and/or odor). Failure is defined by persistence or worsening of symptoms and clinical signs or requirement of an alternative or specific treatment.

  3 months

• Rate of Treatment-related Adverse Events in Subjects Participating in the Clinical Investigation

  The safety of CERVIRON ® as measured by the rate of treatmentrelated adverse events, including serious adverse events (SAEs), in subjects participating in the clinical investigation.

  3 months

Secondary Outcomes (5)

• Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment

  at 1, 2 and 3 months

• Number of Participants With Change in Vaginal pH Values

  at 1, 2 and 3 months

• Number of Participants With Change in Vaginal Microflora and Lactobacilli Count

  3 months

• Number of Participants With Change in Vaginal Inflammation

  3 months

• Results in Patient Satisfaction's Scale (Likert Scale)

  3 months

Study Arms (1)

Cerviron vaginal ovules

EXPERIMENTAL

Since Cerviron® has an innovative composition, we preferred an exploratory approach for the design of the present clinical investigation.

Device: Cerviron

Interventions

Cerviron DEVICE

Cerviron ovules ® is a class IIb medical device indicated as adjuvant in the treatment of acute and chronic vulvovaginitis of mechanical etiology, caused by changes of vaginal pH and changes of the vaginal flora. It is also used in cervical lesions of mechanical origin as it favors the healing and re-epithelialization processes and reduces the proliferation of endogenous pathogens.

Cerviron vaginal ovules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult females, aged 18 years to 65 years;
• Subjects presenting two or more vaginal symptoms such as leucorrhoea, pruritus, burning sensation, erythema, pain, odour, dysuria, or dyspareunia;
• Subjects with a diagnosis of either non-infectious vaginitis, or endogenous, symptomatic infection;
• Negative for Gardnerella vaginalis, Candida albicans, Trichomonas vaginalis;
• Subjects willing to provide signed informed consent to clinical investigation participation.

You may not qualify if:

• Subjects in menstrual period or suffering from menorrhagia;
• Colpectomy;
• Subjects with undiagnosed abnormal genital bleeding;
• Subject with vulvar, vaginal or cervical cancer;
• Known, active sexually transmitted infection (STI) in partner, as per anamnesis;
• Subjects with HIV or other immunodeficiency;
• Subjects with any pathology of the female reproductive organs;
• Known allergy or hypersensitivity to the medical device ingredients;
• Use of spermicides;
• Use of diaphragm;
• Concomitant topical or systemic anti-infective treatment;
• Unable to comply with visit procedures;
• Subjects included in other clinical investigations;

Sponsors & Collaborators

• Perfect Care Distribution: lead
• MDX Research: collaborator

Study Sites (2)

Spitalul Clinic Județean de Urgență "Pius Brinzeu"

Timișoara, Timiș County, Romania

Location

Institutul National pentru Sanatatea Mamei si Copilului (INSMC) "Alessandrescu - Rusescu"

Bucharest, Romania

Location

Related Publications (1)

• Toader DO, Olaru RA, Iliescu DG, Petrita R, Calancea FL, Petre I. Clinical Performance and Safety of Vaginal Ovules in the Local Treatment of Nonspecific Vaginitis: A National, Multicentric Clinical Investigation. Clin Ther. 2023 Sep;45(9):873-880. doi: 10.1016/j.clinthera.2023.06.023. Epub 2023 Jul 18.

  PMID: 37474354 DERIVED

MeSH Terms

Conditions

Vaginitis; Vulvovaginitis; Vaginal Discharge

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvitis; Vulvar Diseases

Results Point of Contact

• Title: Mihnea Mihalache, Chief Executive Officer
• Organization: Perfect Care Distribution

contact@perfectcare.ro

+40 786 749 087

Study Officials

• Ramona Petrita, CSO

  MDX Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: April 1, 2021
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: November 22, 2023
• Results First Posted: November 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

RO (2)