Status:
COMPLETED
Clinical Investigation To Evaluate Cerviron Ovules® in Symptomatic Vaginitis
Lead Sponsor:
Perfect Care Distribution
Collaborating Sponsors:
MDX Research
Conditions:
Vaginitis and Vulvovaginitis
Eligibility:
FEMALE
18-65 years
Phase:
NA
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, Symptoma...
Detailed Description
Vaginitis is the general term characterizing a spectrum of disorders of the vagina caused by infection, inflammation, or changes in the normal vaginal flora. Symptoms include abnormal vaginal discharg...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04735705
Start Date
April 1 2021
End Date
September 9 2021
Last Update
November 22 2023
Active Locations (2)
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1
Spitalul Clinic Județean de Urgență "Pius Brinzeu"
Timișoara, Timiș County, Romania
2
Institutul National pentru Sanatatea Mamei si Copilului (INSMC) "Alessandrescu - Rusescu"
Bucharest, Romania