Vaginal AtrophyPhase 1/2NCT00453089
VG101 Phase I/II to Treat Vulvar and Vaginal Atrophy in Post-Menopausal Women
A Phase 1/2 study testing VG101 in people with Vaginal Atrophy and Vulvar Atrophy, run by Bionovo at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Atrophy, Vulvar Atrophy
- What is being tested?
- VG101
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Aug 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama, Birmingham
Birmingham, Alabama, 35294
Holly Richter, M.D., PhD, 205-934-3180, hrichter@uab.edu
Holly Richter, M.D., PhD
University of California, San Francisco
San Francisco, California, 94115
Deborah Grady, M.D., MPH, 415-353-9748, Deborah.Grady@ucsf.edu
George Sawaya, M.D.
About this 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
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.
Read the 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
- Conditions
- Vaginal Atrophy, Vulvar Atrophy
- Being tested
- VG101
- Keywords
- Chinese Herbs, Postmenopausal, Vaginal Atrophy, Vulvar Atrophy, Symptoms, Bionovo, VG101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VG101Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported symptoms of vaginal atrophy from baseline to 12 weeks
Measured: 4 and 12 weeks
Change in percent superficial vaginal epithelial cells from baseline 12 weeks
Measured: 4 and 12 weeks
Change in the pH of vaginal secretions from baseline to 12 weeks
Measured: 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startJun 2012
- Primary completionJun 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bionovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mary Tagliaferri, MD, Principal investigator, Bionovo, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453089
- Sponsor's protocol ID
- VG-101-001
- Status last verified
- Feb 2012
- First submitted
- 26 Mar 2007
- Last updated
- 8 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00453089
- Acronym / sponsor ID
- VG-101-001
- Conditions
- Vaginal Atrophy, Vulvar Atrophy
- Keywords
- Chinese Herbs, Postmenopausal, Vaginal Atrophy, Vulvar Atrophy, Symptoms, Bionovo, VG101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BionovoIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 28 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- < 5% superficial cells on vaginal cytologic smear.
- Vaginal pH >5.0
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VG101 | Drug | – |
Primary outcome
Change in self-reported symptoms of vaginal atrophy from baseline to 12 weeks
Time frame: 4 and 12 weeks
Change in percent superficial vaginal epithelial cells from baseline 12 weeks
Time frame: 4 and 12 weeks
Change in the pH of vaginal secretions from baseline to 12 weeks
Time frame: 4 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University of California, San Francisco
San Francisco, United States
Mary Tagliaferri, MD principal investigator
Bionovo, Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VG101 in people with Vaginal Atrophy and Vulvar Atrophy, run by Bionovo at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported symptoms of vaginal atrophy from baseline to 12 weeks (time frame: 4 and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2012.