Safety and Efficacy Study of Lactobacillus Administered Vaginally in Women With Bacterial Vaginosis

NCT00635622 | Completed Phase 2 DMC

• 1 other identifier: LV-006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase IIa clinical trial in women with bacterial vaginosis. This study will determine whether treatment with vaginal lactobacillus in combination with antibiotic therapy (metronidazole) is effective in colonizing the vagina with the lactobacillus bacteria found in normal vaginal flora.

Conditions

Bacterial Vaginosis

Keywords

Bacterial Vaginosis; BV; UCSF; SFGH

Outcome Measures

Primary Outcomes (1)

• To evaluate the vaginal colonization efficiency of L. crispatus CTV-05 after vaginal administration of LACTIN-V at 2 x 10^9 cfu/dose (600 mg) daily for 5 days followed by weekly applications over 2 additional weeks

  4 weeks after intervention

Secondary Outcomes (6)

• To evaluate the safety of L. crispatus, LACTIN-V in otherwise healthy pre-menopausal women with BV, immediately after standardized antibiotic treatment with 0.75% topical metronidazole

  10 days and 4 weeks after intervention

• To evaluate the tolerability and acceptability of LACTIN-V as a powder in a pre-filled applicator

  4 weeks after intervention

• To evaluate and compare vaginal flora by Gram stain before and after receipt of LACTIN-V or placebo.

  10 days and 4 weeks after intervention

• To identify and compare bacteria colonizing the vagina at screening in women with bacterial vaginosis and after antibiotic and probiotic treatment.

  Before intervention and 4 weeks after intervention

• To measure and compare the 4 week cure rate of BV after receipt of MetroGel in women who receive LACTIN-V or placebo.

  4 weeks after intervention

Study Arms (2)

1

EXPERIMENTAL

Vaginal application of single-use applicators pre-filled with LACTIN-V (Formulation 1) at 2 x 10\^9 cfu/dose. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.

Drug: LACTIN-V

2

PLACEBO COMPARATOR

Vaginal application of single-use applicators pre-filled with placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.

Drug: Placebo control substance

Interventions

LACTIN-V DRUG

Vaginal application of single-use applicators pre-filled with LACTIN-V (Formulation 1) at 2 x 10\^9 cfu/dose or placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.

1

Placebo control substance DRUG

Vaginal application of single-use applicators pre-filled with placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.

2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Untreated BV (asymptomatic or symptomatic) as diagnosed during the screening visit using Amsel criteria AND confirmed in the laboratory using the Nugent scoring system (Nugent Score ≥ 7).
• Otherwise 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 due to use of a long acting progestin or continuous use of oral contraceptives.
• Subject is willing to insert pre-filled vaginal applicators.
• Subject is willing to be asked questions about personal medical health and sexual history.
• Normal Pap smear collected at the screening visit. If a subject's Visit 0 Pap smear result is any of the following, the person is ineligible for participation: ASC-US (atypical squamous cells of undetermined significance), AGC (atypical glandular cells), ASC-H (atypical squamous cells, cannot r/o high grade lesion), LSIL (low grade squamous intraepithelial lesions), HSIL (high grade squamous intraepithelial lesions), adenocarcinoma in situ, adenocarcinoma, squamous cell carcinoma in situ, squamous cell carcinoma or inadequate sample.
• Vaginal and cervical anatomy that in the opinion of the Investigator lends itself easily to colposcopy.
• Capable of reading and writing English and providing informed consent.
• Previous sexual experience including vaginal intercourse.
• Previous gynecological examinations.
• Currently in a mutually monogamous sexual relationship or not sexually active.
• Agree to be sexually abstinent 72 hours prior to Visit 1 (enrollment) until Visit 2 (Day 10). Also, agree to refrain from intercourse for 48 hours after the study product application on Day 12 and 19 as well as 72 hours before the last study visit on Day 28.
• Agree to abstain from the use of any other intravaginal product (i.e., contraceptive creams, gels, foams, sponges, lubricants, douches, etc.) throughout the trial period, from the time of screening until Day 28.
• Agree to abstain from using tampons throughout the trial period, from the time of screening until Day 28.
• Agree to use an adequate method of birth control for the duration of the study to avoid pregnancy. Acceptable methods include a history of tubal ligation, male partner with a vasectomy, a steroidal contraceptive (oral, patch, injectable or implantable), IUD (Paragard or Mirena), condoms or abstinence.

You may not qualify if:

• Urogenital infection at screening or within the 21 days prior to screening. This includes urinary tract infection, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis or Treponema pallidum. Subjects may be re-screened at least 21 days after the respective antibiotic or antifungal therapies have been completed.
• 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 (all subjects will have a urine pregnancy test prior to enrollment).
• Lactation.
• Vaginal or systemic antibiotic or antifungal therapy within 21 days of the Screening visit or within 30 days of Enrollment visit.
• Investigational drug use within 30 days or 10 half-lives of the drug, whichever is longer, of enrollment visit. Planned investigational drug use while participating in this study.
• Menopause.
• IUD insertion or removal within the last 3 months.
• Pelvic surgery within the last 3 months.
• 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 long-acting treatments (e.g. depot formulation including medroxyprogesterone acetate (DMPA) form of hormonal birth control). Subjects may be enrolled if stable (\> 3months) on existing therapy as determined by the Principal Investigator.
• Diabetes or other significant disease or acute illness that in the Investigator's assessment could complicate the evaluation.
• Known HIV infection or positive HIV test at screening.

Sponsors & Collaborators

• Osel, Inc.: lead
• University of California, San Francisco: collaborator

Study Sites (1)

San Francisco General Hospital (SFGH), University of California, San Francisco (UCSF)

San Francisco, California, 94110, United States

Location

Related Publications (45)

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  PMID: 21992977 DERIVED

• Hemmerling A, Harrison W, Schroeder A, Park J, Korn A, Shiboski S, Foster-Rosales A, Cohen CR. Phase 2a study assessing colonization efficiency, safety, and acceptability of Lactobacillus crispatus CTV-05 in women with bacterial vaginosis. Sex Transm Dis. 2010 Dec;37(12):745-50. doi: 10.1097/OLQ.0b013e3181e50026.

  PMID: 20644497 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Craig R Cohen, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Anke Hemmerling, MD, MPH, PhD

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 14, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: July 10, 2009

Record last verified: 2009-03

Locations

US (1)