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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: | NCT00537576 |
The purpose of this study is to evaluate the safety, tolerability and acceptability of a new formulation of Lactobacillus crispatus, strain CTV-05 (LACTIN-V) in healthy pre-menopausal women. Osel, Inc. proposes that this new formulation will be safe and well-tolerated in healthy pre-menopausal women.
Condition | Intervention | Phase |
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Bacterial Vaginosis |
Drug: LACTIN-V |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase I Study of the Safety of LACTIN-V Administered Vaginally to Healthy Women |
Enrollment: | 12 |
Study Start Date: | November 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
5.0 x 10^8 cfu/dose LACTIN-V
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Drug: LACTIN-V
Arm 1: 5.0 x 10^8 cfu/dose 1x/day x 5 days total intravaginal. Arm 2: 1.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 3: 2.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 4: placebo 1x/day x 5 days total intravaginal.
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2: Experimental
1.0 x 10^9 cfu/dose LACTIN-V
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Drug: LACTIN-V
Arm 1: 5.0 x 10^8 cfu/dose 1x/day x 5 days total intravaginal. Arm 2: 1.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 3: 2.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 4: placebo 1x/day x 5 days total intravaginal.
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3: Experimental
2.0 x 10^9 cfu/dose LACTIN-V
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Drug: LACTIN-V
Arm 1: 5.0 x 10^8 cfu/dose 1x/day x 5 days total intravaginal. Arm 2: 1.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 3: 2.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 4: placebo 1x/day x 5 days total intravaginal.
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4: Placebo Comparator
Placebo
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Drug: LACTIN-V
Arm 1: 5.0 x 10^8 cfu/dose 1x/day x 5 days total intravaginal. Arm 2: 1.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 3: 2.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 4: placebo 1x/day x 5 days total intravaginal.
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The purpose of this study is to demonstrate that the new formulation of L. crispatus CTV-05 (LACTIN-V) is safe and well tolerated in healthy pre-menopausal women when administered vaginally via a pre-filled applicator at a dose of 5.0 x 10^8, 1.0 x 10^9 or 2.0 x 10^9 cfu/dose daily for 5 consecutive days as compared to a placebo control substance containing maltodextrin and a preservation matrix. Safety will be assessed by:
The study will also evaluate the tolerability and acceptability of LACTIN-V in a pre-filled applicator by:
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
San Francisco General Hospital | |
San Francisco, California, United States, 94110 |
Principal Investigator: | Craig Cohen, MD, MPH | University of California, San Francisco |
Responsible Party: | Osel, Inc. ( Peter Lee, MD ) |
Study ID Numbers: | LV-005 |
Study First Received: | September 27, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00537576 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Genital Diseases, Female Bacterial Infections Vaginosis, Bacterial |
Vaginitis Vaginal Diseases Healthy |
Genital Diseases, Female Bacterial Infections Vaginosis, Bacterial Vaginitis Vaginal Diseases |