Safety Study of Lactobacillus Administered Vaginally to Healthy Women

NCT00537576 | Completed Phase 1 Results

• 1 other identifier: LV-005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• Safety of LACTIN-V in Healthy Pre-menopausal Women.

  Safety was measured by comparing the number of women experiencing adverse events of grade 3 or higher during the study.

  35 days

Secondary Outcomes (2)

• Tolerability of LACTIN-V in a Pre-filled Applicator.

  35 days

• Acceptability of LACTIN-V in Pre-filled Applicators

  35 days

Study Arms (6)

Low dose LACTIN-V applicator

EXPERIMENTAL

Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10\^8 CFU), administered vaginally once a day for 5 consecutive days

Biological: Low dose LACTIN-V applicator

Medium dose LACTIN-V applicator

EXPERIMENTAL

Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10\^9 CFU), administered vaginally once a day for 5 consecutive days

Biological: Medium dose LACTIN-V applicator

High dose LACTIN-V applicator

EXPERIMENTAL

High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10\^9 CFU), administered vaginally once a day for 5 consecutive days

Biological: High dose LACTIN-V applicator

Low dose Placebo applicator

PLACEBO COMPARATOR

Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days

Other: Low dose Placebo applicator

Medium dose Placebo applicator

PLACEBO COMPARATOR

Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days

Other: Medium dose Placebo

High dose Placebo applicator

PLACEBO COMPARATOR

High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days

Other: High dose Placebo applicator

Interventions

Low dose LACTIN-V applicator BIOLOGICAL

Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10\^8 CFU), administered vaginally once a day for 5 consecutive days

Also known as: Lactobacillus crispatus CTV-05

Low dose LACTIN-V applicator

Medium dose LACTIN-V applicator BIOLOGICAL

Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10\^9 CFU), administered vaginally once a day for 5 consecutive days

Also known as: Lactobacillus crispatus CTV-05

Medium dose LACTIN-V applicator

High dose LACTIN-V applicator BIOLOGICAL

High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10\^9 CFU), administered vaginally once a day for 5 consecutive days

Also known as: Lactobacillus crispatus CTV-05

High dose LACTIN-V applicator

Low dose Placebo applicator OTHER

Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days

Also known as: Control substance

Low dose Placebo applicator

Medium dose Placebo OTHER

Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days

Also known as: Control substance

Medium dose Placebo applicator

High dose Placebo applicator OTHER

High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days

Also known as: Control substance

High dose Placebo applicator

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (42)

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Related Links

• Click here for more information about this study: LACTIN-V phase I study

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Control Groups

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Anke Hemmerling, Project Director
• Organization: University of California, San Francisco

ahemmerling@globalhealth.ucsf.edu

415-597-4963

Study Officials

• Craig Cohen, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: October 1, 2007
• Study Start: November 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: April 1, 2008
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2014-04

Locations

US (1)