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

February 6, 2012 updated by: Bionovo

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama, Birmingham
    • California
      • San Francisco, California, United States, 94115
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women between the ages of 45 and 65
  2. 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.

  3. 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)
  4. < 5% superficial cells on vaginal cytologic smear.
  5. Vaginal pH >5.0
  6. Willing to use an intravaginal cream containing Chinese herbs for the treatment of vaginal symptoms.
  7. Provide informed consent.

Exclusion Criteria:

  1. History of breast, uterine or ovarian cancer or melanoma.
  2. Abnormal mammogram or breast examination within the last 9 months suggestive of cancer.
  3. Abnormal Pap smear or pelvic examination within the last 9 months suggestive of cancer.
  4. Any uterine or vaginal bleeding within the six months prior to enrollment (except following the screening Pap smear).
  5. Double-wall endometrial thickness that exceeds 5 mm measured on transvaginal ultrasound.
  6. Pregnant or lactating.
  7. Use of any vaginal moisturizer (Replens, KY Silk-E, Astroglide Silken Secret, Senselle) within 30 days of screening.
  8. Use of any oral, transdermal, vaginal, or systemic estrogen or estrogen/progestin product within 30 days of screening.
  9. Use of raloxifene, tamoxifen or aromatase inhibitors within 12 weeks of screening.
  10. Current urinary tract infection (dipstick urinalysis positive for leukocyte estrace, nitrates or blood)
  11. History of cardiovascular disease.
  12. History of venous thromboembolic disease.
  13. Use of another investigational agent within 12 weeks of screening.
  14. 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.
  15. No access to a telephone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in self-reported symptoms of vaginal atrophy from baseline to 12 weeks
Time Frame: 4 and 12 weeks
4 and 12 weeks
Change in percent superficial vaginal epithelial cells from baseline 12 weeks
Time Frame: 4 and 12 weeks
4 and 12 weeks
Change in the pH of vaginal secretions from baseline to 12 weeks
Time Frame: 4 and 12 weeks
4 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bionovo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mary Tagliaferri, MD, Bionovo, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VG-101-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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