Trial Outcomes & Findings for Clinical Investigation To Evaluate Cerviron Ovules® in Symptomatic Vaginitis (NCT NCT04735705)

Last Updated: 2023-11-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

3 months

Results posted on

2023-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Cerviron Vaginal Ovules Since Cerviron® has an innovative composition, we preferred an exploratory approach for the design of the present clinical investigation. Cerviron: 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.
Overall Study STARTED	50
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Investigation To Evaluate Cerviron Ovules® in Symptomatic Vaginitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cerviron Vaginal Ovules n=47 Participants Since Cerviron® has an innovative composition, we preferred an exploratory approach for the design of the present clinical investigation. Cerviron: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.23 Years STANDARD_DEVIATION 10.27 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Childbirth potential	36 Participants n=5 Participants
Subject in menopause	9 Participants n=5 Participants
Subject pregnant	0 Participants n=5 Participants
History of cancer	2 Participants n=5 Participants
Sex life	44 Participants n=5 Participants
Reproductive life	25 Participants n=5 Participants
Tobacco consumption	20 Participants n=5 Participants
Alcohol consumption	0 Participants n=5 Participants
Physical activity	32 Participants n=5 Participants
Rest/Day	34 Participants n=5 Participants
Hydration	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Cerviron Vaginal Ovules n=47 Participants Since Cerviron® has an innovative composition, we preferred an exploratory approach for the design of the present clinical investigation. Cerviron: 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.
Number of Participants With the Same Gynaecological Conditions at the End of Treatment Visit	13 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cerviron Vaginal Ovules n=47 Participants Since Cerviron® has an innovative composition, we preferred an exploratory approach for the design of the present clinical investigation. Cerviron: 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.
Rate of Treatment-related Adverse Events in Subjects Participating in the Clinical Investigation	3 AEs

SECONDARY outcome

Timeframe: at 1, 2 and 3 months

The vaginal discharge assessed by the investigator by using a score: 0=absent 1. mild: insufficient for speculum collection 2. moderate: sufficient for speculum collection 3. abundant: visible at the introitus even before speculum introduction 4. purulent, abnormal discharge: visible at the introitus even before speculum introduction

Outcome measures

Outcome measures
Measure	Cerviron Vaginal Ovules n=47 Participants Since Cerviron® has an innovative composition, we preferred an exploratory approach for the design of the present clinical investigation. Cerviron: 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.
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Purulent - 3 months	0 participants
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Absent - 1 month	2 participants
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Absent - 2 months	8 participants
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Absent - 3 months	9 participants
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Mild - 1 month	26 participants
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Mild - 2 months	21 participants
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Mild - 3 months	13 participants
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Moderate - 1 month	19 participants
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Moderate - 2 months	18 participants
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Moderate - 3 months	25 participants
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Abundant - 1 month	0 participants
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Abundant - 2 months	0 participants
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Abundant - 3 months	0 participants
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Purulent - 1 month	0 participants
Number of Participants With Absent, Mild, Moderate or Abundant Vaginal Discharge at 1, 2 and 3 Months of Treatment Purulent - 2 months	0 participants

SECONDARY outcome

Timeframe: at 1, 2 and 3 months

Determination of pH values compared to its normal values (3.8 - 4.5)

Outcome measures

Outcome measures
Measure	Cerviron Vaginal Ovules n=47 Participants Since Cerviron® has an innovative composition, we preferred an exploratory approach for the design of the present clinical investigation. Cerviron: 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.
Number of Participants With Change in Vaginal pH Values Normal - 1 month	41 Participants
Number of Participants With Change in Vaginal pH Values Normal - 2 months	44 Participants
Number of Participants With Change in Vaginal pH Values Normal - 3 months	47 Participants
Number of Participants With Change in Vaginal pH Values Abnormal - 1 month	6 Participants
Number of Participants With Change in Vaginal pH Values Abnormal - 2 months	3 Participants
Number of Participants With Change in Vaginal pH Values Abnormal - 3 months	0 Participants

SECONDARY outcome

Timeframe: 3 months

The change in Lactobacillus species as shown by microscopy

Outcome measures

Outcome measures
Measure	Cerviron Vaginal Ovules n=47 Participants Since Cerviron® has an innovative composition, we preferred an exploratory approach for the design of the present clinical investigation. Cerviron: 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.
Number of Participants With Change in Vaginal Microflora and Lactobacilli Count Yeast cells and filaments present	2 Participants
Number of Participants With Change in Vaginal Microflora and Lactobacilli Count Lactobacilli present	30 Participants
Number of Participants With Change in Vaginal Microflora and Lactobacilli Count Leukocytes present	38 Participants
Number of Participants With Change in Vaginal Microflora and Lactobacilli Count Enterobact. present	0 Participants
Number of Participants With Change in Vaginal Microflora and Lactobacilli Count Squamous epithelial cells present	0 Participants
Number of Participants With Change in Vaginal Microflora and Lactobacilli Count Gardnerella vaginalis present	2 Participants
Number of Participants With Change in Vaginal Microflora and Lactobacilli Count Trich. vaginalis present	0 Participants
Number of Participants With Change in Vaginal Microflora and Lactobacilli Count Candida present	2 Participants

SECONDARY outcome

Timeframe: 3 months

The change in inflammatory and parabasal cells by microscopy

Outcome measures

Outcome measures
Measure	Cerviron Vaginal Ovules n=47 Participants Since Cerviron® has an innovative composition, we preferred an exploratory approach for the design of the present clinical investigation. Cerviron: 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.
Number of Participants With Change in Vaginal Inflammation	32 Participants

SECONDARY outcome

Timeframe: 3 months

The degree of satisfaction when using the medical device will be assessed using a five-point Likert Scale. The degree of satisfaction when using the medical device was assessed using a five-point Likert Scale, as very satisfied, satisfied, neutral, unsatisfied, and very unsatisfied.

Outcome measures

Outcome measures
Measure	Cerviron Vaginal Ovules n=47 Participants Since Cerviron® has an innovative composition, we preferred an exploratory approach for the design of the present clinical investigation. Cerviron: 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.
Results in Patient Satisfaction's Scale (Likert Scale) Very Satisfied	39 Participants
Results in Patient Satisfaction's Scale (Likert Scale) Satisfied	6 Participants
Results in Patient Satisfaction's Scale (Likert Scale) Neutral	2 Participants
Results in Patient Satisfaction's Scale (Likert Scale) Unsatisfied	0 Participants
Results in Patient Satisfaction's Scale (Likert Scale) Very Unsatisfied	0 Participants

Adverse Events

Cerviron Vaginal Ovules

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cerviron Vaginal Ovules n=47 participants at risk Since Cerviron® has an innovative composition, we preferred an exploratory approach for the design of the present clinical investigation. Cerviron: 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.
Infections and infestations Streptococcus infection	2.1% 1/47 • Number of events 1 • During all the clinical investigation No significant adverse events (AEs) were reported during this clinical investigation.
Infections and infestations E. Coli infection	2.1% 1/47 • Number of events 1 • During all the clinical investigation No significant adverse events (AEs) were reported during this clinical investigation.

Additional Information

Mihnea Mihalache, Chief Executive Officer

Perfect Care Distribution

Phone: +40 786 749 087

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place