Safety, Tolerability and Efficacy of Vaginal Suppository WO3191 in the Post-treatment of Bacterial Vaginosis
Condition: Vaginosis, Bacterial
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional

Summary: 
      Bacterial Vaginosis (BV) is a common infectious disorder and is characterized by a
      disturbance in the vaginal microbiological milieu. Anaerobic bacteria, such as Gardnerella
      vaginalis and Atopobium vaginae overgrow the physiologic vaginal flora which is dominated by
      Lactobacilli. BV can arise and remit spontaneously but often presents as a recurrent disease.

      New findings indicate that the presence of an adherent bacterial biofilm on the vaginal
      mucosa seems to be the reason for the recurrence of BV as well as the overgrowth condition by
      anaerobic bacteria. Biofilms are defined as a structured consortium of bacteria embedded in a
      matrix of extracellular polymeric substances (EPS).

      The purpose of this study is to achieve substantial results with respect to tolerability and
      safety, and to gain further knowledge on the clinical efficacy of Vaginal suppository WO3191,
      the investigation will be performed in a parallel-design, double-blind, randomised,
      controlled manner.
    

Detailed description: 
      This investigation is a multicentre, parallel-group, double-blind, controlled trial with an
      open Follow-up Phase of 12 weeks. It is conducted to gain clinical experience and further
      knowledge about the certified medical device Vaginal suppository WO3191 in women with
      bacterial vaginosis.

      In this investigation the Investigational Medical Device (IMD) will be used as post-treatment
      following standard therapy with oral metronidazole for BV. IMD will be applied 2 times a week
      for 3 weeks.

      The primary purpose is the evaluation of the safety and local tolerability of WO3191,
      therefore all adverse events (AEs) and adverse device effects (ADEs) will be documented.
      Furthermore, patients will be asked for possibly arising subjective vaginal symptoms
      (burning, itching, bleeding, pain, dryness) and will be examined for possibly arising
      objective vaginal findings (redness, petechial bleeding, dryness, swelling).

      The secondary purpose of this investigation is to gain clinical experience and further
      knowledge about Vaginal suppository WO3191 with respect to the efficacy in the post-treatment
      of bacterial vaginosis.

      In addition pH-values and microbiological data shall be examined.

      Furthermore, the difference between Vaginal suppository WO3191 (Group A) and the comparator
      (Vagisan® Lactic Acid, group B) with respect to the safety, tolerability and the efficacy in
      the post-treatment of bacterial vaginosis shall be evaluated exploratively.

      Patients who have completed all regular visits (Visit 1 - 4; Visit 1 - Screening, Visit 2 -
      Randomization, Start of application of IMD; Visit 3 - one week after Visit 2; Visit 4 - two
      weeks after Visit 3, End of application of IMD) of the investigation shall attend an
      observational Follow-up Phase of 12 weeks with a final Visit 5. At Visit 5 recurrences of BV
      as well as the sustainability of the efficacy of Vaginal suppository WO3191 will be
      evaluated.
    

Intervention name(s): Medical Device: WO3191; Medical Device: Vagisan® Lactic Acid
Intervention type(s): Other; Other
Intervention description(s): application of vaginal suppository WO3191: 2 days per week (with a treatment-free interval of three days or two days, respectively; e.g. Monday and Friday); application of Vagisan® Lactic Acid: 2 days per week (with a treatment-free interval of three days or two days, respectively; e.g. Monday and Friday)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bacterial Vaginosis; BV