Once Daily In-situ Forming Versus Twice-daily Conventional Metronidazole Vaginal Gels for Treatment of Bacterial Vaginosis
Condition: Vaginitis
MeSH terms: Vaginitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A previous study showed that in situ MTZ vaginal gel twice daily is more effective than the
      conventional vaginal gel product in sustained cure of BV( 4 weeks after treatment) (80.0% in
      the in-situ gel group as compared with 47.4 in the conventional gel group.The current study
      aims to compare the efficacy of the use of once daily in situ MTZ vaginal gel (0.8%) versus
      twice-daily conventional MTZ vaginal gel in treatment of BV.
    

Detailed description: 
      Bacterial vaginosis (BV) is one of the most frequently diagnosed infections in women
      attending genitourinary clinics. As 50% of cases of BV are asymptomatic, the true prevalence
      of this condition in the community is uncertain.Metronidazole (MTZ) is considered the drug of
      choice for the treatment of BV. It can be given either orally or locally. Formulations for
      the local administration of the drug include gels and suppositories.

      The acceptance of suppositories is lower than the oral administration of the drug as they
      might cause irritation and thus affecting the patient's compliance. Moreover, the mode of
      administration of MTZ does not have a significant difference in the eradication of the
      pathogenic bacteria .

      Among the metronidazole gels and lactic acid gels, for local application, lactic acid gels
      have been found to be more efficient and safer. The recurrence of BV is less common in
      patients treated with lactic acid gel when compared with patients treated with metronidazole
      gels. This may be attributed to the inhibition in the growth of the lactobacilli when MTZ is
      used for the treatment and depends on the concentration of the lactobacilli .

      Intravaginal deliveries of MTZ for the treatment of BV have shown that there was an
      improvement in the clinical symptoms of the patients within 21-30 days of the starting of the
      treatment. Unfortunately, the vagina was not recolonized with lactobacilli within the stated
      period . The use of formulation consisting policarbophil-carbopol and lactic acid-chitosan
      mucoadhesive vaginal gels has also been reported and both of them have been found to be safe
      .

      Cure rates following intravaginal treatment with MTZ account for 80-90% at the end of
      treatment and one month after the end of therapy. However, three months after the end of
      therapy the rate of relapses can overcome 30%. Persistence of an adherent bacterial biofilm,
      containing mostly Gardenerlla vaginalis is the main reason for failure of BV treatment .

      Suppressive treatment with MTZ gel has been investigated with variable results . Moreover,
      long-term treatment with MTZ is not recommended because of the high incidence of
      gastrointestinal adverse reactions, the risk of peripheral neuropathy, and Candida super
      infection.

      Although the patients are known to tolerate gels better than suppositories or ointments, the
      direct application of gels into the diseased sites of vagina might be difficult as well as
      improper. Therefore, vaginal therapy would be significantly improved if an intravaginally
      administered drug can retain at the site of administration for prolonged time .

      The in situ forming hydrogel is a stimuli sensitive hydrogel that exists as an aqueous
      solution before administration. When exposed to external physical stimuli like heat, it
      undergoes reversible volume-phase transition, then immediately turned into standing gels
      after its contact with the mucosa .Recently, in situ gel drug delivery system has been
      investigated as a more convenient dosage form of topical applications. It's easy to be
      applied into the vagina with accurate dosing of liquid before turning to gel with even
      spreading. It had been tried before and proved effectiveness, safety and tolerance .
    

Intervention name(s): MTZ vaginal gel; Conventional MTZ vaginal gel
Intervention type(s): Drug; Drug
Intervention description(s): MTZ vaginal gel once daily for 5 days; Conventional MTZ vaginal gel (Tricho gel 0.8%, Sedico, Egypt) twice daily for 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment