Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453089
Status:
UNKNOWN
Last Update Posted:
2012-02-08
First Post:
2007-03-26
Brief Title:
VG101 Phase III to Treat Vulvar and Vaginal Atrophy in Post-Menopausal Women
Sponsor:
Bionovo
Organization:
Bionovo
Study Overview
Official Title:
A Phase III Dose Escalation Clinical Trial to Assess Safety and Efficacy of VG101 to Treat the Symptoms of Vulvar and Vaginal Atrophy in Post-Menopausal Women
Status:
UNKNOWN
Status Verified Date:
2012-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To conduct a prospective randomized blinded placebo controlled dose escalation clinical trial in 4 cohorts of 10 postmenopausal women total N40 aged 45 to 65 years with at least one menopausal vaginal symptom vaginal pH 50 and 20 parabasal vaginal epithelial cells
Detailed 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 andor vaginal dryness
relieve vulvar andor vaginal irritation
relieve vulvar andor vaginal itching
relieve vulvar andor 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
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 andor vaginal dryness
relieve vulvar andor vaginal irritation
relieve vulvar andor vaginal itching
relieve vulvar andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None