Clinical Investigation To Evaluate Cerviron Ovules® in Symptomatic Vaginitis
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|ClinicalTrials.gov Identifier: NCT04735705|
Recruitment Status : Completed
First Posted : February 3, 2021
Last Update Posted : September 10, 2021
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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.
|Condition or disease||Intervention/treatment||Phase|
|Vaginitis and Vulvovaginitis||Device: Cerviron||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 1, 2021|
|Actual Primary Completion Date :||September 9, 2021|
|Actual Study Completion Date :||September 9, 2021|
Experimental: Cerviron vaginal ovules
Since Cerviron® has an innovative composition, we preferred an exploratory approach for the design of the present clinical investigation.
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.
- Clinical Performance Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit [ Time Frame: 3 months ]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.
- Rate of treatment-related Adverse Events in subjects participating in the clinical investigation [ Time Frame: 3 months ]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.
- Change in Vaginal Discharge Aspect during Clinical Exam, Assessed by the Investigator [ Time Frame: at 1, 2 and 3 months ]
The vaginal discharge assessed by the investigator by using a score:
- mild: insufficient for speculum collection
- moderate: sufficient for speculum collection
- abundant: visible at the introitus even before speculum introduction
- purulent, abnormal discharge: visible at the introitus even before speculum introduction
- Change in vaginal pH values [ Time Frame: at 1, 2 and 3 months ]Determination of pH values compared to its normal values (3.8 - 4.5)
- Change in vaginal microflora and Lactobacilli count [ Time Frame: 3 months ]The change in Lactobacillus species as shown by microscopy
- Change in vaginal inflammation [ Time Frame: 3 months ]The change in inflammatory and parabasal cells by microscopy
- Patient Satisfaction (Likert Scale) [ Time Frame: 3 months ]The degree of satisfaction when using the medical device will be assessed using a five-point Likert Scale.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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.
- Subjects in menstrual period or suffering from menorrhagia;
- 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;
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735705
|Spitalul Clinic Județean de Urgență "Pius Brinzeu"|
|Timisoara, Timiș, Romania|
|Institutul National pentru Sanatatea Mamei si Copilului (INSMC) "Alessandrescu - Rusescu"|
|Study Director:||Ramona Petrita, CSO||MDX Research|
|Responsible Party:||Perfect Care Distribution|
|Other Study ID Numbers:||
|First Posted:||February 3, 2021 Key Record Dates|
|Last Update Posted:||September 10, 2021|
|Last Verified:||August 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
vaginal discharge, vaginal pH, vaginal microflora