Safety Study of Lactobacillus Administered Vaginally to Healthy Women
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety, tolerability, and acceptability of
      LACTIN-V (Active Ingredient: Lactobacillus crispatus CTV-05) with a matching placebo at three
      doses using pre-filled vaginal applicators in healthy pre-menopausal women. The study
      hypothesis is that LACTIN-V will be safe, tolerable, and acceptable at each dose and will not
      differ significantly from the placebo controls.
    

Detailed description: 
      The purpose of this study is to demonstrate that LACTIN-V is safe, well tolerated, and
      acceptable to healthy pre-menopausal women when administered vaginally using pre-filled
      applicators at doses of 150 mg (5.0 x 10^8 CFU), 300 mg (1.0 x 10^9 CFU), or 600 mg (2.0 x
      10^9 CFU) daily for 5 consecutive days as compared to placebo applicators containing 150 mg,
      300 mg, or 600 mg of a matching placebo formulation without Lactobacillus crispatus CTV-05.

      Safety will be assessed by:

        -  Incidence and severity of adverse events through assessing symptoms, physical
           examination findings, and signs of irritation involving the external genitalia, cervix
           or vagina, including disruption of the epithelium and blood vessels as seen on pelvic
           examination and colposcopy.

        -  Laboratory parameters including urinalysis, a complete blood count (CBC) with
           differential, and chemistry panels to assess systemic effects of the study product.

      Tolerability will be assessed by:

        -  The proportion of participants who discontinue study product use due to overt adverse
           events

        -  The proportion of participants who complete the full dosing schedule

      Acceptability will be assessed by:

      - Self-administered questionnaires and focus group discussions about acceptability of the
      study product
    

Intervention name(s): Low dose LACTIN-V applicator; Medium dose LACTIN-V applicator; High dose LACTIN-V applicator; Low dose Placebo applicator; Medium dose Placebo; High dose Placebo applicator
Intervention type(s): Biological; Biological; Biological; Other; Other; Other
Intervention description(s): Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU), administered vaginally once a day for 5 consecutive days; Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days; High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days; Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days; Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days; High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days
Other intervention name(s): Lactobacillus crispatus CTV-05; Lactobacillus crispatus CTV-05; Lactobacillus crispatus CTV-05; Control substance; Control substance; Control substance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other