Safety Study of Lactobacillus Administered Vaginally to Healthy Women

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

March 31, 2008

Study Completion Date

April 30, 2008

Conditions
Bacterial Vaginosis
Interventions
BIOLOGICAL

Low dose LACTIN-V applicator

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

Medium dose LACTIN-V applicator

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

High dose LACTIN-V applicator

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

OTHER

Low dose Placebo applicator

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

OTHER

Medium dose Placebo

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

OTHER

High dose Placebo applicator

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

Trial Locations (1)

94110

San Francisco General Hospital, San Francisco

All Listed Sponsors
collaborator

University of California, San Francisco

OTHER

lead

Osel, Inc.

INDUSTRY

NCT00537576 - Safety Study of Lactobacillus Administered Vaginally to Healthy Women | Biotech Hunter | Biotech Hunter