Suppression Of Bacterial Vaginosis (BV) [SUBVert]
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase II randomized, double-blind, placebo-controlled study screening approximately 600
      adult females, aged 18-55, with a goal to enroll approximately 250 participants to achieve
      200 evaluable participants at the test of cure (TOC) visit. The study is designed to
      determine the clinical efficacy of an investigational product (IP), TOL-463 Insert, in
      suppressing Recurrent Bacterial Vaginosis (RBV) when administered to women who have a history
      of RBV and have been successfully cleared of their current Bacterial Vaginosis (BV) infection
      administering 500 mg of oral metronidazole, twice a day for 7 days or another CDC-recommended
      BV treatment. Patient participation will be approximately 100 days while the study is
      conducted at 4 sites within the United States. The primary objective of the study is to
      evaluate the clinical efficacy of a twice-weekly application of TOL-463 vaginal insert in
      suppression of BV in women with a history of RBV following successful induction with oral
      metronidazole or a CDC-recommended BV treatment.
    

Detailed description: 
      This is a Phase II randomized, double-blind, placebo-controlled study screening approximately
      600 adult females, aged 18-55, with a goal to enroll approximately 250 participants to
      achieve 200 evaluable participants at the test of cure (TOC) visit. The study is designed to
      determine the clinical efficacy of an investigational product (IP), TOL-463 Insert, in
      suppressing Recurrent Bacterial Vaginosis (RBV) when administered to women who have a history
      of RBV and have been successfully cleared of their current Bacterial Vaginosis (BV) infection
      administering 500 mg of oral metronidazole, twice a day for 7 days or another CDC-recommended
      BV treatment. Patient participation will be approximately 100 days while the study is
      conducted at 4 sites within the United States. The primary objective of the study is to
      evaluate the clinical efficacy of a twice-weekly application of TOL-463 vaginal insert in
      suppression of BV in women with a history of RBV following successful induction with oral
      metronidazole or a CDC-recommended BV treatment. Secondary objectives of the study are: 1) to
      evaluate the time to BV recurrence as defined by clinical criteria, 2) to evaluate the
      incidence of vaginal symptoms over study participation, 3) to evaluate acceptability of a
      twice-weekly application of TOL-463 vaginal insert in suppression of BV, and 4) to evaluate
      the safety of TOL-463 vaginal insert compared to placebo, including the incidence of
      secondary vulvovaginal candidiasis (VVC). The null hypothesis for the comparison is that
      there is no difference in cure rates between treatments, with a two-sided alternative.
    

Intervention name(s): Placebo; TOL-463
Intervention type(s): Other; Drug
Intervention description(s): Placebo vaginal inserts.; TOL-463 is a non-azole vaginal anti-infective drug candidate designed as a dual-indication therapy for BV and VVC.
Intervention MeSH terms: TOL-463
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bacterial vaginosis; Candida albicans; Double-Blind; Gardnerella vaginalis; Phase II; Placebo; Randomized; Suppression; TOL-463 insert