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

Sponsored by:	Bionovo
Information provided by:	Bionovo
ClinicalTrials.gov Identifier:	NCT00453089

Purpose

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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

Resource links provided by NLM:

MedlinePlus related topics: Menopause

U.S. FDA Resources

Further study details as provided by Bionovo:

Primary Outcome Measures:

Change in self-reported symptoms of vaginal atrophy from baseline to 12 weeks [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: No ]
Change in percent superficial vaginal epithelial cells from baseline 12 weeks [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: No ]
Change in the pH of vaginal secretions from baseline to 12 weeks [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2010
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Detailed Description:

Primary Aims:

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.
Specific potential adverse effects of VG101

Secondary Aims:

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
participant adherence to VG101 administration

Eligibility

Ages Eligible for Study:	45 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Women between the ages of 45 and 65
Postmenopausal documented by: (a) at least one year of amenorrhea; (b) 6- 12 months of amenorrhea with serum FSH > 40 IU/ml; (c) 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, or (d) hysterectomy with serum FSH levels > 40 IU/ml.
Self-report at least one moderate to severe symptom of vulvar or vaginal atrophy from the following list:
- Vaginal dryness (none, mild, moderate or severe)
- Vaginal and/or vulvar discomfort (none, mild, moderate, severe)
- Vaginal and/or vulvar irritation (none, mild, moderate, severe)
- Vaginal itching (none, mild, moderate, severe)
- Vaginal pain associated with sexual activity (none, mild, moderate or severe)
< 5% superficial cells on vaginal cytologic smear.
Vaginal pH >5.0
Willing to use an intravaginal cream containing Chinese herbs for the treatment of vaginal symptoms.
Provide informed consent.

Exclusion Criteria:

History of breast, uterine or ovarian cancer or melanoma.
Abnormal mammogram or breast examination within the last 9 months suggestive of cancer.
Abnormal Pap smear or pelvic examination within the last 9 months suggestive of cancer.
Any uterine or vaginal bleeding within the six months prior to enrollment (except following the screening Pap smear).
Double-wall endometrial thickness that exceeds 5 mm measured on transvaginal ultrasound.
Pregnant or lactating.
Use of any vaginal moisturizer (Replens, KY Silk-E, Astroglide Silken Secret, Senselle) within 30 days of screening.
Use of any oral, transdermal, vaginal, or systemic estrogen or estrogen/progestin product within 30 days of screening.
Use of raloxifene, tamoxifen or aromatase inhibitors within 12 weeks of screening.
Current urinary tract infection (dipstick urinalysis positive for leukocyte estrace, nitrates or blood)
History of cardiovascular disease.
History of venous thromboembolic disease.
Use of another investigational agent within 12 weeks of screening.
Any medical or psychiatric condition that, in the investigator's opinion, would preclude the participant from completing questionnaires or measures, adhering to the protocol or completing the trial, including limited English literacy, severe illness, plans to move, substance abuse, significant psychiatric problems, or dementia.
No access to a telephone

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453089

Contacts

Contact: Azin Olyaie, MS

(510) 420-4163

azin.olyaie@bionovo.com

Locations

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

Sponsors and Collaborators

Bionovo

Investigators

Principal Investigator:

Mary Tagliaferri, MD

Bionovo, Inc

More Information

No publications provided

Responsible Party:	Bionovo, Inc ( Mary Tagliaferri, MD )
Study ID Numbers:	VG-101-001
Study First Received:	March 26, 2007
Last Updated:	August 21, 2009
ClinicalTrials.gov Identifier:	NCT00453089 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Bionovo:

Chinese Herbs
Postmenopausal
Vaginal Atrophy
Vulvar Atrophy

Symptoms
Bionovo
VG101

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Atrophy
Marijuana Abuse
Menopause

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Atrophy

ClinicalTrials.gov processed this record on September 10, 2009