LACTIN-V Study for Recurrent Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2b trial is designed to provide a screening evaluation for the hypothesis that,
      following a 5-day treatment with MetroGel® to treat BV, L. crispatus CTV-05 (LACTIN-V, Osel,
      Inc.) administered at 2 x 10^9 cfu/dose using a vaginal applicator reduces the 12-week
      incidence of BV recurrence when compared to placebo. The primary objectives of this study
      are: 1) To estimate the efficacy of repeated doses of LACTIN-V (2 x 10^9 cfu/dose) as
      compared to placebo in preventing BV recurrence by 12 weeks following treatment of BV with
      MetroGel vaginal gel (MetroGel). 2) To assess the safety of LACTIN-V over 24 weeks by
      comparing the incidence of AEs between individuals randomized to LACTIN-V or placebo.
    

Detailed description: 
      This is a Phase II-b multicenter randomized double-blind placebo-controlled trial to assess
      the efficacy of repeated doses of LACTIN-V compared to placebo in preventing BV recurrence in
      women diagnosed with BV. The study will also assess the safety of LACTIN-V by comparing the
      incidence of AEs between women randomized to LACTIN-V or placebo. The study plans to enroll
      228 non-pregnant, pre-menopausal women age 18 to 45 years. Women will be randomized 2:1 to
      receive LACTIN-V or placebo. Potentially eligible women will start a standard 5-day course of
      MetroGel. Women will return to the study clinic within 2 days after completing the 5-day
      course of MetroGel to re-evaluate eligibility criteria and review the BV test results from
      the screening visit. Women with Amsel criteria > /=3 and Nugent score 4-10 will be instructed
      to administer the LACTIN-V or placebo at home for 5 consecutive days and then twice weekly
      for 10 weeks. The primary objectives of this study are: 1) To estimate the efficacy of
      repeated doses of LACTIN-V (2 x109 cfu/dose) as compared to placebo in preventing BV
      recurrence by 12 weeks following treatment of BV with MetroGel vaginal gel (MetroGel). 2) To
      assess the safety of LACTIN-V over 24 weeks by comparing the incidence of AEs between
      individuals randomized to LACTIN-V or placebo. Secondary objectives are: 1) To investigate
      the colonization of LACTIN-V (presence of L. crispatus CTV-05 in the vaginal specimen) and
      fluctuations over 12 weeks, in relation to menses and sexual intercourse 2) To evaluate user
      acceptability and tolerability of LACTIN-V over 12 weeks, including perceptions around method
      of delivery and dosing. 3) To measure long-term colonization of LACTIN-V at 24 weeks (12
      weeks after last dosing) 4) To estimate the long-term efficacy of repeated doses of LACTIN-V
      (2 x 109 cfu/dose) as compared to placebo in preventing BV recurrence at 24 weeks (12 weeks
      after last dosing)
    

Intervention name(s): Lactobacillus crispatus CTV-05; Metronidazole; Placebo
Intervention type(s): Biological; Drug; Other
Intervention description(s): LACTIN-V is an intravaginal live biotherapeutic product composed of Lactobacillus crispatus CTV-05 (LACTIN-V, Osel Inc) in a vaginal applicator. Subjects receive 2x10^9 cfu/dose applied vaginally daily x 5 days then twice weekly x 10 weeks.; Metronidazole is a nitroimidazole. Metronidazole gel (MetroGel) is applied vaginally 7.5 mg/gm daily for 5 days; Placebo formulation applied vaginally, daily x 5 days then twice weekly x 10 weeks.
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: CTV-05; LACTIN-V; Lactobacillus; MetroGel®; Vaginitis