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VG101 Phase I/II to Treat Vulvar and Vaginal Atrophy in Post-Menopausal Women

NCT00453089 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-02-08

No results posted yet for this study

Summary

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.

Conditions

  • Vaginal Atrophy
  • Vulvar Atrophy

Interventions

DRUG

VG101

Sponsors & Collaborators

  • Bionovo

    lead INDUSTRY

Principal Investigators

  • Mary Tagliaferri, MD · Bionovo, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-06-30
Completion
2013-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00453089 on ClinicalTrials.gov