Back to results

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

Primary Purpose

Vaginal Atrophy, Vulvar Atrophy

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VG101

About this trial

This is an interventional treatment trial for Vaginal Atrophy focused on measuring Chinese Herbs, Postmenopausal, Vaginal Atrophy, Vulvar Atrophy, Symptoms, Bionovo, VG101

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University of Alabama, Birmingham
University of California, San Francisco

Outcomes

Primary Outcome Measures

Change in self-reported symptoms of vaginal atrophy from baseline to 12 weeks

Change in percent superficial vaginal epithelial cells from baseline 12 weeks

Change in the pH of vaginal secretions from baseline to 12 weeks

Secondary Outcome Measures

Full Information

NCT ID

NCT00453089

First Posted

March 26, 2007

Last Updated

February 6, 2012

Sponsor

Bionovo

1. Study Identification

Unique Protocol Identification Number

NCT00453089

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2013 (Anticipated)

Study Completion Date

August 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Bionovo

4. Oversight

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaginal Atrophy, Vulvar Atrophy

Keywords

Chinese Herbs, Postmenopausal, Vaginal Atrophy, Vulvar Atrophy, Symptoms, Bionovo, VG101

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

VG101

Primary Outcome Measure Information:

Title

Change in self-reported symptoms of vaginal atrophy from baseline to 12 weeks

Time Frame

4 and 12 weeks

Title

Change in percent superficial vaginal epithelial cells from baseline 12 weeks

Time Frame

4 and 12 weeks

Title

Change in the pH of vaginal secretions from baseline to 12 weeks

Time Frame

4 and 12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary Tagliaferri, MD

Organizational Affiliation

Bionovo, Inc

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama, Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Holly Richter, M.D., PhD

Phone

205-934-3180

hrichter@uab.edu

First Name & Middle Initial & Last Name & Degree

Holly Richter, M.D., PhD

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Deborah Grady, M.D., MPH

Phone

415-353-9748

Deborah.Grady@ucsf.edu

First Name & Middle Initial & Last Name & Degree

George Sawaya, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs