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

Vaginal Atrophy Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

Primary Aims:

1. the optimal dose of VG101 based on the highest of 4 proposed dose levels that is not associated with unacceptable toxicity during 12 weeks of treatment. Toxicity will be based on National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 3. Unacceptable toxicity will be defined as the occurrence of any Grade 3, 4, of 5 toxicity that is possibly or probably associated with study drug or any other unacceptable toxicity as determined by the Data and Safety Monitoring Board.

2. Specific potential adverse effects of VG101

Secondary Aims:

1. the preliminary efficacy of VG101 to:

- relieve vulvar and/or vaginal dryness,

- relieve vulvar and/or vaginal irritation

- relieve vulvar and/or vaginal itching

- relieve vulvar and/or vaginal discharge

- relieve dyspareunia

- improve sexual function

- relieve dysuria

- reduce frequency of urinary incontinence

- improve quality of life

- improve the physical examination assessment of vaginal atrophy

- reduce vaginal fluid pH

- improve the proportion of superficial vaginal epithelial cells

2. participant adherence to VG101 administration ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00453089
Study type Interventional
Source Bionovo
Contact
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date June 2012
Completion date August 2013
View Details
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