Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, Double-Blind, Randomized, Placebo-Controlled, Multi-center Trial
      enrolling 120 subjects with Bacterial Vaginosis who will be randomized at a ratio of 2:1 to
      receive active test article (5% Monolaurin Vaginal Gel) or placebo (vehicle). The primary
      objective is to assess the safety and tolerability of 5% Monolaurin Vaginal Gel compared to
      vehicle placebo gel (excipients only) and to assess the efficacy by clinical cure rate of 5%
      Monolaurin Vaginal Gel compared to vehicle placebo gel at Visit 2.
    

Detailed description: 
      Bacterial vaginosis (BV) is a disease of the vagina caused by bacteria. The most common
      symptom of BV is an abnormal homogeneous off-white vaginal discharge (especially after sex)
      with an unpleasant smell. This is a Phase II, Double-Blind, Randomized, Placebo-Controlled,
      Multi-center Trial enrolling 120 women, 18-50 years old, with clinical evidence of bacterial
      vaginosis. Subjects will be randomized at a ratio of 2:1 to receive active test article (5%
      Monolaurin Vaginal Gel) or placebo (vehicle) as outpatient therapy. Subjects will be
      stratified by first time episode of bacterial vaginosis or recurrent bacterial vaginosis. The
      primary objectives of this study are: 1) To assess the safety and tolerability of 5%
      Monolaurin Vaginal Gel compared to Vehicle Placebo Gel (excipients only) and 2) To assess the
      efficacy by clinical cure rate of 5% Monolaurin Vaginal Gel compared to Vehicle Placebo Gel
      at Visit 2. The secondary objectives are : 1) To evaluate the therapeutic cure rate of 5%
      Monolaurin Vaginal Gel compared to Vehicle Placebo Gel at Visits 2 and 3, 2) To evaluate the
      clinical cure rate of 5% Monolaurin Vaginal Gel compared to Vehicle Placebo Gel at Visit 3,
      3) To evaluate the changes in Nugent's criteria of vaginal bacterial flora at Visits 2 and 3.
      This study is expected to last for 13 months, with subject participation duration being 4
      weeks.
    

Intervention name(s): 5% Monolaurin Vaginal Gel; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration , and commonly referred to as glycerol monolaurate (GML). Each subject will receive intravaginal gel twice daily for three successive days for a total of 6 doses. There will be 3 clinic visits over 30 days.; The placebo gel is a clear to opaque, colorless to light gray, non-sterile glycol-based gel for vaginal administration. The placebo gel contains the same excipients as the Monolaurin vaginal gel. Each subject will receive intravaginal gel twice daily for three successive days for a total of 6 doses. There will be 3 clinic visits over 30 days.
Intervention MeSH terms: Monolaurin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bacterial Vaginosis; Monolaurin Vaginal Gel