VaginitisNCT05652959
Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis
An observational study of Vaginitis and Bacterial Vaginosis, run by Perfect Care Distribution at 10 sites in Romania.
Trial summary
Vaginitis is a broad term that includes a range of gynecological disorders characterized by infection of vaginal mucosa, inflammation of vulva and alteration of the normal vaginal microflora. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Vaginitis, Bacterial Vaginosis
- What is being tested?
- Cerviron®
- Type of treatment
- Medical device
- How many people
- 111 participants
- Where
- 10 sitesRomania
- Study dates
- 20 May 2021to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Adult, Older adult
Study population: Women aged between 20 and 70 years were treated with Cerviron® ovules as monotherapy and Cerviron® ovules as supportive treatment in conjunction with the antibiotic therapy having specific symptoms such as leukorrhea, vaginal itching, pain and a feeling of tension, vaginal burning, erythema, abnormal odor of vaginal secretions, dysuria and dyspareunia.
Who may be able to join
- Adult females with a diagnosis of infectious or non-infectious vaginitis and treated with Cerviron® with or without anti-infectious treatment for at least three months:
- Negative result for Gardnerella vaginalis, Candida albicans, Trichomonas vaginalis.
Who cannot join
- Subjects with diagnosed abnormal genital bleeding;
- Subject with vulvar, vaginal or cervical cancer;
- Subjects with other inflammatory gynecological conditions.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Romania10 sites
Spitalul Clinic Dr. Ion Cantacuzino Bucharest
Bucharest
Med Life Humanitas Cluj-Napoca
Cluj-Napoca
Cabinet Medical - Dr. Saleh K. Majed
Craiova
Cabinet Medical - Dr. Surpanelu Oana
Iași
Clinica Natisan Pitesti
Piteşti
Cabinet Dr. Rădulescu G. Mihaela Elena
Râmnicu Vâlcea
Pan Medical Sibiu
Sibiu
Cabinet Dr. Ioana Trotea Targu Jiu
Târgu Jiu
Clinica Medicala Dr. Cioata Ionel Trifon
Timișoara
Spitalul Judetean de Urgenta Tulcea
Tulcea
About this study
Official title: Real-world Performance and Safety of Cerviron® Medical Device in the Treatment of Various Types of Vaginitis
Vaginitis is a broad term that includes a range of gynecological disorders characterized by infection of vaginal mucosa, inflammation of vulva and alteration of the normal vaginal microflora. The most prevalent is bacterial vaginosis, followed by other clinical entities such as candidiasis, trichomoniasis and non-specific vaginitis.
A collection of clinical data was conducted to assess the tolerability of Cerviron® ovules in the treatment and management of various types of vaginitis in clinical practice. A total of 111 women aged between 20 and 70 years were recruited, 71 of whom were treated with Cerviron® ovules as monotherapy and 40 who used Cerviron® ovules as supportive treatment in conjunction with antibiotic therapy. The aim of our study was to assess the relief in vaginal symptoms and changes in the normal vaginal pH level after 3 months of treatment with Cerviron® medical device in real-life clinical practice settings.
Read the detailed description
This study was designed as real-world evidence study with the primary purpose to assess the performance and tolerance of Cerviron® ovules in the treatment and management of various types of vulvovaginitis. The study collected clinical data from 28 different specialized gynecology clinical facilities. The study was conducted between May 20, 2021 and August 31, 2021.
The primary objective of this study was to assess the tolerability of Cerviron® ovules in the treatment and management of various types of vulvovaginitis, but also to confirm its performance both on symptoms relief and as a user-friendly device. The secondary objective of this study was to assess the performance of the medical device by clinical exam and patients' degree of satisfaction. The study design consisted of 3 or 4 visits over 90 ± 3 days. Cerviron® ovules were applied intravaginally, once per day, on the first day after menstruation and for 15 days during 3 consecutive months.
Data of 111 women aged between 20 and 70 years were analyzed, 71 of whom were treated with Cerviron® ovules as monotherapy and 40 who used Cerviron® ovules as supportive treatment in conjunction with anti-infectious therapy.
The symptoms recorded in the medical charts were followed to determine the performance of the medical device during the treatment.
- Conditions
- Vaginitis, Bacterial Vaginosis
- Being tested
- Cerviron®
- Keywords
- vulvovaginitis, vaginal discharge, vaginal pH
- Medical subject headings
- Vaginitis, Vaginosis, Bacterial, Vulvovaginitis, Vaginal Discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerviron®Device
Cerviron® is a medical device manufactured by PFC Pharma Manufacturing SL formulated following the provisions of the European Regulation 2017/745 on Medical Devices. Cerviron® is an invasive medical device of short-term use classified under annex VIII of the European Regulation 2017/745 as class IIb according to Rule 21. Cerviron® has a complex composition consisting of three topical pharmaceutical products - hexylresorcinol, collagen and bismuth subgallate - and four phytotherapeutic extracts - Calendula officinalis, Hydrastis canadensis, Thymus vulgaris extract and Curcuma longa. The Instructions for use specify its field of use 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 and of cervical lesions of mechanical origin.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the medical device
the number of possible adverse Number of reactions observed during the treatment
Measured: 3 months
Secondary outcomes (4)
Improvement in the vaginal discharge aspect
Presence/absence of abnormal/normal vaginal discharge
Measured: 3 months
Improvement in the association of vaginal symptoms (burn and pain)
Presence/absence of vaginal symptoms (burn and pain)
Measured: 3 months
Improvement in vaginal irritation
Presence/absence of vaginal irritation
Measured: 3 months
Measurement of vaginal pH
Normalization of vaginal pH values
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start20 May 2021
- Primary completion20 Mar 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perfect Care Distribution
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MDX Research
- Responsible party
- Sponsor
- Investigators
- Ema Peta, Study director, Perfect Care Distribution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652959
- Sponsor's protocol ID
- CYRONRW/01/2022
- Status last verified
- Apr 2023
- First submitted
- 18 Nov 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
Publications
Hainer BL, Gibson MV. Vaginitis. Am Fam Physician. 2011 Apr 1;83(7):807-15.
PubMed 21524046Saraf VS, Sheikh SA, Ahmad A, Gillevet PM, Bokhari H, Javed S. Vaginal microbiome: normalcy vs dysbiosis. Arch Microbiol. 2021 Sep;203(7):3793-3802. doi: 10.1007/s00203-021-02414-3. Epub 2021 Jun 13.
PubMed 34120200Verstraelen H, Verhelst R, Vaneechoutte M, Temmerman M. Group A streptococcal vaginitis: an unrecognized cause of vaginal symptoms in adult women. Arch Gynecol Obstet. 2011 Jul;284(1):95-8. doi: 10.1007/s00404-011-1861-6. Epub 2011 Feb 19.
PubMed 21336834Coudray MS, Madhivanan P. Bacterial vaginosis-A brief synopsis of the literature. Eur J Obstet Gynecol Reprod Biol. 2020 Feb;245:143-148. doi: 10.1016/j.ejogrb.2019.12.035. Epub 2019 Dec 24.
PubMed 31901667Owen MK, Clenney TL. Management of vaginitis. Am Fam Physician. 2004 Dec 1;70(11):2125-32.
PubMed 15606061Brown H, Drexler M. Improving the Diagnosis of Vulvovaginitis: Perspectives to Align Practice, Guidelines, and Awareness. Popul Health Manag. 2020 Oct;23(S1):S3-S12. doi: 10.1089/pop.2020.0265.
PubMed 32997581
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Performance and Safety of Cerviron® Medical Device in the Treatment of Various Types of Vaginitis
- ClinicalTrials.gov ID
- NCT05652959
- Acronym / sponsor ID
- CYRONRW/01/2022
- Conditions
- Vaginitis, Bacterial Vaginosis
- Keywords
- vulvovaginitis, vaginal discharge, vaginal pH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Perfect Care DistributionIndustry (pharma, biotech, devices)
- Collaborators
- MDX Research
- Study start
- 20 May 2021 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vaginitis is a broad term that includes a range of gynecological disorders characterized by infection of vaginal mucosa, inflammation of vulva and alteration of the normal vaginal microflora. The most prevalent is bacterial vaginosis, followed by other clinical entities such as candidiasis, trichomoniasis and non-specific vaginitis.
A collection of clinical data was conducted to assess the tolerability of Cerviron® ovules in the treatment and management of various types of vaginitis in clinical practice. A total of 111 women aged between 20 and 70 years were recruited, 71 of whom were treated with Cerviron® ovules as monotherapy and 40 who used Cerviron® ovules as supportive treatment in conjunction with antibiotic therapy. The aim of our study was to assess the relief in vaginal symptoms and changes in the normal vaginal pH level after 3 months of treatment with Cerviron® medical device in real-life clinical practice settings.
Detailed description
This study was designed as real-world evidence study with the primary purpose to assess the performance and tolerance of Cerviron® ovules in the treatment and management of various types of vulvovaginitis. The study collected clinical data from 28 different specialized gynecology clinical facilities. The study was conducted between May 20, 2021 and August 31, 2021.
The primary objective of this study was to assess the tolerability of Cerviron® ovules in the treatment and management of various types of vulvovaginitis, but also to confirm its performance both on symptoms relief and as a user-friendly device. The secondary objective of this study was to assess the performance of the medical device by clinical exam and patients' degree of satisfaction. The study design consisted of 3 or 4 visits over 90 ± 3 days. Cerviron® ovules were applied intravaginally, once per day, on the first day after menstruation and for 15 days during 3 consecutive months.
Data of 111 women aged between 20 and 70 years were analyzed, 71 of whom were treated with Cerviron® ovules as monotherapy and 40 who used Cerviron® ovules as supportive treatment in conjunction with anti-infectious therapy.
The symptoms recorded in the medical charts were followed to determine the performance of the medical device during the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women aged between 20 and 70 years were treated with Cerviron® ovules as monotherapy and Cerviron® ovules as supportive treatment in conjunction with the antibiotic therapy having specific symptoms such as leukorrhea, vaginal itching, pain and a feeling of tension, vaginal burning, erythema, abnormal odor of vaginal secretions, dysuria and dyspareunia.
Key inclusion criteria (2 listed)
- Adult females with a diagnosis of infectious or non-infectious vaginitis and treated with Cerviron® with or without anti-infectious treatment for at least three months:
- Negative result for Gardnerella vaginalis, Candida albicans, Trichomonas vaginalis.
Key exclusion criteria (3 listed)
- Subjects with diagnosed abnormal genital bleeding;
- Subject with vulvar, vaginal or cervical cancer;
- Subjects with other inflammatory gynecological conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerviron®Cerviron® is a medical device manufactured by PFC Pharma Manufacturing SL formulated following the provisions of the European Regulation 2017/745 on Medical Devices. Cerviron® is an invasive medical device of short-term use classified under annex VIII of the European Regulation 2017/745 as class IIb according to Rule 21. Cerviron® has a complex composition consisting of three topical pharmaceutical products - hexylresorcinol, collagen and bismuth subgallate - and four phytotherapeutic extracts - Calendula officinalis, Hydrastis canadensis, Thymus vulgaris extract and Curcuma longa. The Instructions for use specify its field of use 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 and of cervical lesions of mechanical origin. | Device | – |
Primary outcome
Safety of the medical device
Time frame: 3 months
the number of possible adverse Number of reactions observed during the treatment
4 secondary outcomes
Improvement in the vaginal discharge aspect
Time frame: 3 months
Improvement in the association of vaginal symptoms (burn and pain)
Time frame: 3 months
Improvement in vaginal irritation
Time frame: 3 months
Measurement of vaginal pH
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Background: PubMed 21524046Hainer BL, Gibson MV. Vaginitis. Am Fam Physician. 2011 Apr 1;83(7):807-15.
- Background: PubMed 34120200Saraf VS, Sheikh SA, Ahmad A, Gillevet PM, Bokhari H, Javed S. Vaginal microbiome: normalcy vs dysbiosis. Arch Microbiol. 2021 Sep;203(7):3793-3802. doi: 10.1007/s00203-021-02414-3. Epub 2021 Jun 13.
- Background: PubMed 21336834Verstraelen H, Verhelst R, Vaneechoutte M, Temmerman M. Group A streptococcal vaginitis: an unrecognized cause of vaginal symptoms in adult women. Arch Gynecol Obstet. 2011 Jul;284(1):95-8. doi: 10.1007/s00404-011-1861-6. Epub 2011 Feb 19.
- Background: PubMed 31901667Coudray MS, Madhivanan P. Bacterial vaginosis-A brief synopsis of the literature. Eur J Obstet Gynecol Reprod Biol. 2020 Feb;245:143-148. doi: 10.1016/j.ejogrb.2019.12.035. Epub 2019 Dec 24.
- Background: PubMed 15606061Owen MK, Clenney TL. Management of vaginitis. Am Fam Physician. 2004 Dec 1;70(11):2125-32.
- Background: PubMed 32997581Brown H, Drexler M. Improving the Diagnosis of Vulvovaginitis: Perspectives to Align Practice, Guidelines, and Awareness. Popul Health Manag. 2020 Oct;23(S1):S3-S12. doi: 10.1089/pop.2020.0265.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ema Peta study director
Perfect Care Distribution
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginitis and Bacterial Vaginosis, run by Perfect Care Distribution at 10 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the medical device (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05652959, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.