An observational study in Vaginitis and Bacterial Vaginosis, sponsored by Perfect Care Distribution. Completed at 10 sites in Romania. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Perfect Care Distribution · Observational
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.
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.
240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
This study's enrollment of 111 is below the median of 350 across 30 observational studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Perfect Care Distribution is the lead sponsor of 6 studies on the registry; none are open to participants now.
Compared within Vaginosis, Bacterial, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Vaginitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Safety of the medical device
the number of possible adverse Number of reactions observed during the treatment
Time frame: 3 months
Improvement in the vaginal discharge aspect
Presence/absence of abnormal/normal vaginal discharge
Time frame: 3 months
Improvement in the association of vaginal symptoms (burn and pain)
Presence/absence of vaginal symptoms (burn and pain)
Time frame: 3 months
Improvement in vaginal irritation
Presence/absence of vaginal irritation
Time frame: 3 months
Measurement of vaginal pH
Normalization of vaginal pH values
Time frame: 3 months
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Perfect Care Distribution