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Sponsors and Collaborators: |
Osel, Inc. University of California, San Francisco |
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Information provided by: | Osel, Inc. |
ClinicalTrials.gov Identifier: | NCT00635622 |
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.
Condition | Intervention | Phase |
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Bacterial Vaginosis |
Drug: LACTIN-V Drug: Placebo control substance |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IIa Study of the Colonization Efficiency, Safety and Acceptability of LACTIN-V Administered Vaginally to Women With Bacterial Vaginosis |
Estimated Enrollment: | 40 |
Study Start Date: | April 2008 |
Study Completion Date: | January 2009 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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.
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Drug: LACTIN-V
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.
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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.
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Drug: Placebo control substance
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.
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Phase IIa randomized, double blind, placebo-controlled, clinical trial of LACTIN-V at 2 x 10^9 cfu/dose versus placebo, administered vaginally with a pre-filled applicator once daily for five consecutive days followed by a weekly dose over 2 additional weeks after an initial standardized antibiotic treatment with 0.75% topical metronidazole (MetroGel). A single site will enroll 40 participants (30 randomized to LACTIN-V and 10 to placebo).
Colonization rate of Lactobacillus crispatus CTV 05 will be assessed with culture and rep-PCR.
Safety will be determined by comparing the incidence of adverse events and serious adverse events in the LACTIN-V and placebo groups as determined by clinical symptoms, physical examination, pelvic examination with colposcopy and laboratory measurements. Tolerability will be measured by percentage of subjects who discontinue study product use due to overt adverse events and percentage of subjects who adhere to complete dosing schedule. Acceptability will be assessed via a standardized questionnaire and focus group discussions.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
San Francisco General Hospital (SFGH), University of California, San Francisco (UCSF) | |
San Francisco, California, United States, 94110 |
Principal Investigator: | Craig R Cohen, MD, MPH | University of California, San Francisco |
Study Director: | Anke Hemmerling, MD, MPH, PhD | University of California, San Francisco |
Responsible Party: | Osel, Inc. ( Peter Lee, MD ) |
Study ID Numbers: | LV-006 |
Study First Received: | March 10, 2008 |
Last Updated: | March 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00635622 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Bacterial Vaginosis BV UCSF SFGH |
Genital Diseases, Female Bacterial Infections Vaginosis, Bacterial Vaginitis Vaginal Diseases |
Genital Diseases, Female Bacterial Infections Vaginosis, Bacterial Vaginitis Vaginal Diseases |