Clinical Investigation To Evaluate Cerviron Ovules® in Symptomatic Vaginitis
Condition: Vaginitis and Vulvovaginitis
MeSH terms: Vaginitis; Vulvovaginitis
Study type: Interventional

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.
    

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 discharge, odour, pruritus, pain, dysuria and/or discomfort. Moreover, vaginitis is
      responsible for the most common problems in clinical medicine, and it is the reason cited
      most often for visits to obstetricians and gynecologists. In the past years, the problem of
      vaginitis has all too often been ignored by the medical community or regarded merely as a
      minor annoyance to women. According to Gardner, "Vaginitis must cause more unhappiness on
      earth than any other gynecologic disease. In addition to the many physical and emotional
      problems associated with vaginitis, the economic loss involved is of astronomic proportions."
      The most common causes of vaginitis are bacterial vaginosis, vulvovaginal candidiasis, and
      trichomoniasis. Bacterial Vaginosis is the cause in 40% to 50% of cases in which a cause is
      identified, with vulvovaginal candidiasis accounting for 20% to 25% and trichomoniasis for
      15% to 20% of cases. The standard of care currently is based on anti-infectious therapy. With
      the availability of complementary and alternative therapies and over-the-counter medications
      for vaginitis, many symptomatic women seek these products before or in addition to an
      evaluation by a medical provider. However, recurrence of vaginosis is frequent, and can
      include four or more episodes in one year.

      Non-infectious cases, including atrophic, irritant, and inflammatory vaginitis, are less
      common and account for 5% to 10% of vaginitis cases. Obtaining a medical history alone has
      been shown to be insufficient for accurate diagnosis of vaginitis and can lead to the
      inappropriate administration of medication. Therefore, a careful history, examination, and
      laboratory testing to determine the etiology of vaginal symptoms are needed. Information on
      sexual behaviors and practices, gender of sex partners, menses, vaginal hygiene practices
      (e.g., douching), and self-treatment with medications should be collected.

      Other causes of vaginitis There is no cause of vagini¬tis identified in up to 30% of women.
      These women may have a range of conditions, includ¬ing irritant or allergic vaginitis,
      atrophic vaginitis, or physiologic discharge. The presence of objective signs of vulvar
      inflammation in the absence of vaginal pathogens after laboratory testing suggests the
      possibility of mechanical, chemical, allergic, or other non-infectious causes of vulvovaginal
      signs or symptoms.

      Inflammatory vagi¬nitis is an uncommon condition characterized by purulent vaginal discharge,
      burning, and dyspa¬reunia, and should be considered in patients with these symptoms if no
      infectious cause is found. Inflammatory vaginitis is associated with low estrogen levels,
      such as in menopausal or perimenopausal women.

      Desquamative inflammatory vaginitis is a chronic inflammatory process involving both vagina
      and vestibule, occurring almost exclusively in white women, that responds well to topical
      anti-inflammatory therapy. Long-term maintenance therapy is frequently required.

      Irritant/allergic vaginitis is characterized by symptoms such as burning and soreness and
      signs such as vulvar erythema.

      Atrophic vaginitis is an uncommon condition that occurs as a consequence of estrogen
      deficiency and is characterized by symptoms such as thin, clear discharge, vaginal dryness,
      dyspareunia, itching. An examination of the vulva can indicate inflammation and thin and
      friable vaginal mucosa. Risk factors contributing to atrophic vaginitis are menopause,
      lactation, oophorectomy, radiation therapy, chemotherapy, immunologic disorders, premature
      ovarian failure, endocrine disorders, and antioestrogen medications.

      Aerobic vaginitis is a distinct vaginal condition, requiring different clinical management
      and with distinct clinical risks. (7) Aerobic vaginitis is defined by disruption in
      Lactobacillus dominance but is accompanied by more extreme inflammatory changes than BV and
      the presence of mainly aerobic enteric commensals or pathogens, including Group B
      Streptococcus (S. agalactiae), Enterococcus faecalis, Escherichia coli, and S. aureus.
      Streptococcus agalactiae (group B Streptococcus, GBS) vaginal pathogenicity is not uniformly
      acknowledged throughout the literature. GBS virulence for vagina was recognized in the past,
      as the organism has been observed to potentially cause local inflammation and discharge, as
      well as lactobacilli rarefaction.

      Cytolitytic vaginosis is another condition which has been recently described as an entity
      distinct from either normal flora or bacterial vaginosis. This condition, also called
      Doderlein's vaginitis, has numerous, active lactobacilli damaging epithelial cells because of
      extreme acidity and low pH. The bare nuclei and cellular debris that are seen during
      microscopy, should not be mistaken for leucocytes and cocci.

      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.

      This is the first clinical investigation on human subjects with this medical device, in which
      50 patients will be enlisted, and which will take place in two research centres in Romania.
    

Intervention name(s): Cerviron
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaginitis; vaginal discharge, vaginal pH, vaginal microflora