LACTIN-V Study for Recurrent Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: Lactobacillus crispatus CTV-05; Metronidazole; Placebo
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 228.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: CTV-05; LACTIN-V; Lactobacillus; MetroGel®; Vaginitis

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.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Capable of reading and writing English and voluntarily provide written informed consent
        to participate in the study and comply with all study procedures 2. Untreated BV
        (asymptomatic or symptomatic) as diagnosed during the screening visit defined by >/=3 Amsel
        criteria. Note: Amsel criteria include the following: --Homogeneous, thin, grayish-white
        discharge that smoothly coats the vaginal walls; --Vaginal pH >4.5; --Positive whiff-amine
        test, defined as the presence of a fishy odor when a drop of 10% potassium hydroxide (KOH)
        is added to a sample of vaginal discharge; --Presence of clue cells (>20% on microscopy).
        3. Untreated BV(asymptomatic or symptomatic) as confirmed in the laboratory using the
        Nugent scoring system (Nugent Score >/= 4) 4. Otherwise healthy pre-menopausal women 18-45
        years of age on the day of screening 5. Regular predictable menstrual cycles or amenorrheic
        for at least 3 months due to use of a long-acting progestin or continuous use of oral
        contraceptives 6. Willing to be asked questions about personal medical health and sexual
        history. 7. Willing to apply study agent vaginally and comply with study examinations. 8.
        Agree to abstain from sexual intercourse during the first 5 consecutive days of study
        product administration, 12 hours prior to study visits and for 12 hours after each study
        product application 9. Agree to abstain from the use of any other intravaginal product
        throughout the trial period from the time of screening through Visit 7 (Week 24, Day 168)
        Note: Intravaginal products include contraceptive creams such as Gynol II, gels, foams,
        sponges, lubricants not approved by the study investigators, and douches. Limit use of
        tampons during menstruation to unscented products. 10. Must be of non-childbearing
        potential or if of childbearing potential, must agree to use a reliable method of birth
        control for the duration of the study Note: Reliable methods of birth control include tubal
        ligation, male partner with a vasectomy, a steroidal contraceptive (oral, patch, injectable
        or implantable), IUD, condoms or abstinence.

        Exclusion Criteria:

        1. Urogenital infection at screening Note: Urogenital infection includes urinary tract
        infection, Trichomonas (T.) vaginalis, Neisseria (N.) gonorrhoeae, Chlamydia (C.)
        trachomatis, Treponema (T.) pallidum, or vulvo-vaginal candidiasis. 2. Diagnosis of two or
        more outbreaks of N. gonorrhoeae, C. trachomatis, T. pallidum, T. vaginalis, or herpes
        simplex virus (herpes genitalis) within 6 months prior to screening 3. Positive for
        syphilis or HIV at screening 4. Current pregnancy or within 2 months of last pregnancy
        and/or currently breastfeeding**. Criteria will be assessed at screening and enrollment. 5.
        Vaginal or systemic antibiotic or antifungal therapy (other than MetroGel given as part of
        study procedures) within 21 days of screening or within 30 days of enrollment** 6. Use of
        disulfiram within past 2 weeks or other contraindication to use of MetroGel** 7. Any
        condition requiring regular periodic use of systemic antibiotics during participation in
        the trial 8. Active genital herpes lesion** (if not resolved by enrollment)** 9.
        Investigational drug use other than LACTIN-V within 30 days or 10 half-lives of the drug,
        whichever is longer, of enrollment visit** 10. Other planned participation in an
        investigational drug study while participating in this study** 11. Menopause defined as
        more than 12 consecutive months of amenorrhea without another known cause including
        pregnancy 12. IUD insertion or removal, pelvic surgery, cervical cryotherapy or cervical
        laser treatment within the last 2 months prior to screening 13. Use of vaginal ring (eg,
        NuvaRing) within 3 days of screening or during the course of the study** 14. Failure to
        complete 5 days of MetroGel with the last dose taken no later than 48 hours prior to
        randomization*** 15. Use of new long-acting hormonal treatments. Participant may be
        enrolled if stable (>3 months) on existing therapy as determined by the principal
        investigator** 16. Known allergy to any component of LACTIN-V/placebo or MetroGel or to
        nitroimidazole derivatives or latex (condoms) 17. Any social, medical, or psychiatric
        condition, including history of drug or alcohol abuse that in the opinion of the
        investigator would make it unlikely for the participant to comply with the study ** Note:
        Criteria will be assessed at screening and enrollment. ***Note: Criteria will be assessed
        at enrollment