Safety Study of Lactobacillus Administered Vaginally to Healthy Women
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial
Intervention: 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 description: 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
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy pre-menopausal women 18- 40 years of age at date of screening.

          -  Regular menstrual cycles (21-35 days) or amenorrheic for at least 3 months (long
             acting progestin contraceptives).

          -  Normal Pap smear collected at the screening visit.

          -  Previous sexual experience including vaginal intercourse.

          -  Previous experience of gynecological examinations.

          -  Currently in a mutually monogamous sexual relationship or not sexually active.

          -  Agree to be sexually abstinent thoughout the trial.

          -  Agree to abstain from the use of any other intravaginal product thoughout the trial

          -  Agree to use an adequate method of birth control for the duration of the study to
             avoid pregnancy.

        Exclusion Criteria:

          -  Urogenital infection at screening or within the 21 days prior to screening (UTI,
             bacterial vaginosis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia
             trachomatis, Treponema pallidum or Herpes simplex).

          -  History of recurrent genital herpes.

          -  Diagnosis of N. gonorrhoeae, C. trachomatis, T. pallidum or T. vaginalis on two or
             more occasions during the six months prior to screening.

          -  Pregnancy or within 2 months of last pregnancy.

          -  Lactation.

          -  Antibiotic or antifungal therapy within 30 days of enrollment visit.

          -  Concurrent investigational drug use within 30 days or 10 half-lives of the drug, of
             enrollment visit or during the study.

          -  Menopause.

          -  IUD insertion or removal, pelvic surgery, cervical cryotherapy or cervical laser
             within the last 3 months.

          -  Use of a NuvaRing® within 3 days of the screening visit or during the course of the
             study.

          -  New (less than 3 months)long-acting treatments (e.g. depot formulation including
             medroxyprogesterone acetate (DMPA) form of hormonal birth control). - - Diabetes or
             other significant disease or acute illness.

          -  Known HIV infection or positive HIV test at screening.

          -  Immunosuppressive drug within 60 days.

          -  Previous participation in a L. crispatus CTV-05 clinical study.

          -  Colposcopic findings at the enrollment visit involving significant deep disruption of
             the epithelium.

          -  Abnormal results for the pap smear at the screening visit.

          -  Known allergy to any component of LACTIN-V, other significant drug allergy or to latex
             (condoms).

          -  Known drug or alcohol abuse.