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Sponsored by: |
Bionovo |
Information provided by: | Bionovo |
ClinicalTrials.gov Identifier: | NCT00453089 |
To conduct a prospective, randomized, blinded, placebo controlled, dose escalation clinical trial in 4 cohorts of 10 postmenopausal women (total N=40) aged 45 to 65 years with at least one menopausal vaginal symptom, vaginal pH > 5.0 and > 20% parabasal vaginal epithelial cells.
Condition | Intervention | Phase |
Vaginal Atrophy Vulvar Atrophy |
Drug: VG101 |
Phase I Phase II |
MedlinePlus related topics: | Menopause |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Dose Escalation Clinical Trial to Assess Safety and Efficacy of VG101 to Treat the Symptoms of Vulvar and Vaginal Atrophy in Post-Menopausal Women |
Estimated Enrollment: | 40 |
Study Start Date: | January 2008 |
Primary Aims:
Secondary Aims:
the preliminary efficacy of VG101 to:
Ages Eligible for Study: | 45 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Self-report at least one moderate to severe symptom of vulvar or vaginal atrophy from the following list:
Exclusion Criteria:
Contact: Mary Tagliaferri, M.D. | (510) 601-2000 | clinicaltrials@bionovo.com |
United States, Alabama | |||||
University of Alabama, Birmingham | |||||
Birmingham, Alabama, United States, 35294 | |||||
United States, California | |||||
University of California, San Francisco | |||||
San Francisco, California, United States, 94115 |
Bionovo |
Principal Investigator: | Deborah Grady, M.D., MPH | University of California, San Francisco |
Study ID Numbers: | VG-101-001 |
First Received: | March 26, 2007 |
Last Updated: | May 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00453089 |
Health Authority: | United States: Institutional Review Board |
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