N/A
N=50
Clinical Investigation To Evaluate Cerviron Ovules® in Symptomatic Vaginitis
Vaginitis and Vulvovaginitis
Bottom Line
View on ClinicalTrials.gov: NCT04735705 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Number of Participants With the Same Gynaecological Conditions at the End of Treatment Visit — 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cerviron (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Perfect Care Distribution
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Same Gynaecological Conditions at the End of Treatment Visit |
13 | — |
| PRIMARY Rate of Treatment-related Adverse Events in Subjects Participating in the Clinical Investigation |
3 | — |
| SECONDARY Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment |
2; 8; 9; 26; 21; 13 | — |
| SECONDARY Number of Participants With Change in Vaginal pH Values |
41; 44; 47; 6; 3; 0 | — |
| SECONDARY Number of Participants With Change in Vaginal Microflora and Lactobacilli Count |
30; 38; 0; 0; 2; 0 | — |
| SECONDARY Number of Participants With Change in Vaginal Inflammation |
32 | — |
| SECONDARY Results in Patient Satisfaction's Scale (Likert Scale) |
39; 6; 2; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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;
Data sourced from ClinicalTrials.gov (NCT04735705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.