Vaginosis, BacterialPhase 2NCT01055106
Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis
A Phase 2 study testing GW05 and Metronidazole in people with Vaginosis, Bacterial and Vaginal Infection, run by Graceway Pharmaceuticals, LLC at 20 sites in United States.
Trial summary
The objective of this study is to evaluate the efficacy and safety of GW05 administered in 3 regimens versus metronidazole 0.75% for the treatment of bacterial vaginosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginosis, Bacterial, Vaginal Infection
- What is being tested?
- GW05 and Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 20 sitesUnited States
- Study dates
- Jan 2010to Apr 2010
- Phase
- Phase 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females at least 18 years of age
- In good general health
- Confirmed current diagnosis of bacterial vaginosis (determined at study screening)
- Negative pregnancy test (for women who are able to become pregnant)
- Must abstain from sexual intercourse throughout the first 7 days of thes study
- Must abstain from alcohol ingestion during the treatment period and for one day afterward
- Must not use intra-vaginal products for the duration of the study
Who cannot join
- Pregnant, lactating, or planning to become pregnant during the study period
- Menstruating at the time of the diagnosis or anticipate the onset of menses during the treatment phase of the study
- Had a medical event within 90 days of the visit (e.g., stroke, heart attack, etc.)
- Received specific treatments/medications /therapy within the designated time period prior to study enrollment
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Women's Partners in Health
Austin, Texas, 78705
Women's Health Practice
Champaign, Illinois, 61820
Downtown Women's Healthcare
Denver, Colorado, 80218
Grand Rapids Women's Health
Grand Rapids, Michigan, 49503
ActivMed Practices & Research
Haverhill, Massachusetts, 01830
TMC Life Research
Houston, Texas, 77054
Jackson Clinic
Jackson, Tennessee, 38305
NEA Women's Clinic
Jonesboro, Arkansas, 72401
Adams Patterson OBGYN
Memphis, Tennessee, 38120
Miami Research Associates
Miami, Florida, 33143
Tidewater Physicians for Women
Norfolk, Virginia, 23502
Segal Institiute for Clinical Research
North Miami, Florida, 33161
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Women's Health Research
Phoenix, Arizona, 85015
Precision Trials
Phoenix, Arizona, 85032
Women's Health Research Center
Plainsboro, New Jersey, 08536
All Women's Healthcare of West Broward
Plantation, Florida, 33324
Atlanta North Gynecology
Roswell, Georgia, 30075
Saginaw Valley Medical Research Group
Saginaw, Michigan, 48604
Women's Health Center Inc
San Diego, California, 92123
About this study
Official title: A Multicenter, Randomized, Investigator-Blinded, Phase 2, Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis
The objective of this study is to evaluate the efficacy and safety of GW05 administered in 3 regimens versus metronidazole 0.75% for the treatment of bacterial vaginosis.
Read the detailed description
This is a multicenter, randomized, investigator-blinded, phase 2, dose ranging study of GW05 vaginal gel administered in 3 regimens compared to metronidazole 0.75% (QD x 5 days) for the treatment of bacterial vaginosis. Subjects will be evaluated at three timepoints (1 screening/baseline visit, post-treatment phone call and 1 test-of-cure visit). The total study duration may be up to 30 days for a subject.
Study medication will be applied intravaginally once daily at bedtime according to the assigned dosing schedule using the supplied 5-gram vaginal applicators.
Investigator blinding will be ensured by utilizing an independent drug dispensing coordinator at each site.
Bacterial vaginosis (BV) is an infection of the vagina (birth canal) that is the result of an overgrowth of bacteria that are often normally found in the vagina. This type of vaginal infection typically does not cause irritation. The most common complaint of patients who suffer from BV is a fishy-smelling vaginal discharge. The amount of vaginal discharge may or may not be increased above a normal discharge. The bad odor may get worse after sexual intercourse or during the menstrual period. BV is also strongly associated with problems during pregnancy, such as premature (early) birth, and with an increased risk of sexually transmitted diseases. Therefore, it is important to treat the infection.
- Conditions
- Vaginosis, Bacterial, Vaginal Infection
- Being tested
- GW05, Metronidazole
- Keywords
- bacterial vaginosis, vaginal infection, vaginal discharge, vaginal disease
- Medical subject headings
- Vaginosis, Bacterial, Vaginitis, Vaginal Discharge, Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW05Drug
vaginal gel once daily regimen A
GW05Drug
vaginal gel once daily regimen B
GW05Drug
vaginal gel once daily regimen C
MetronidazoleDrug
vaginal gel 0.75% once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1D | Active comparator | Not described Receives: Drug: GW05 |
| 3D | Active comparator | Not described Receives: Drug: GW05 |
| 5D | Active comparator | Not described Receives: Drug: GW05 |
| Metronidazole | Active comparator | Not described Receives: Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of subjects with therapeutic cure
Measured: day 21 to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginosis, BacterialStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Graceway Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sharon F Levy, MD, Study director, Graceway Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055106
- Sponsor's protocol ID
- GW05-0904
- Status last verified
- Jun 2011
- First submitted
- 21 Jan 2010
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Chavoustie SE, Jacobs M, Reisman HA, Waldbaum AS, Levy SF, Hillier SL, Nyirjesy P. Metronidazole vaginal gel 1.3% in the treatment of bacterial vaginosis: a dose-ranging study. J Low Genit Tract Dis. 2015 Apr;19(2):129-34. doi: 10.1097/LGT.0000000000000062.
PubMed 24983350
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Investigator-Blinded, Phase 2, Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT01055106
- Acronym / sponsor ID
- GW05-0904
- Conditions
- Vaginosis, Bacterial, Vaginal Infection
- Keywords
- bacterial vaginosis, vaginal infection, vaginal discharge, vaginal disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Graceway Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 25 Jan 2010 (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.
The objective of this study is to evaluate the efficacy and safety of GW05 administered in 3 regimens versus metronidazole 0.75% for the treatment of bacterial vaginosis.
Detailed description
This is a multicenter, randomized, investigator-blinded, phase 2, dose ranging study of GW05 vaginal gel administered in 3 regimens compared to metronidazole 0.75% (QD x 5 days) for the treatment of bacterial vaginosis. Subjects will be evaluated at three timepoints (1 screening/baseline visit, post-treatment phone call and 1 test-of-cure visit). The total study duration may be up to 30 days for a subject.
Study medication will be applied intravaginally once daily at bedtime according to the assigned dosing schedule using the supplied 5-gram vaginal applicators.
Investigator blinding will be ensured by utilizing an independent drug dispensing coordinator at each site.
Bacterial vaginosis (BV) is an infection of the vagina (birth canal) that is the result of an overgrowth of bacteria that are often normally found in the vagina. This type of vaginal infection typically does not cause irritation. The most common complaint of patients who suffer from BV is a fishy-smelling vaginal discharge. The amount of vaginal discharge may or may not be increased above a normal discharge. The bad odor may get worse after sexual intercourse or during the menstrual period. BV is also strongly associated with problems during pregnancy, such as premature (early) birth, and with an increased risk of sexually transmitted diseases. Therefore, it is important to treat the infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1D | Active comparator | Drug: GW05 |
| 3D | Active comparator | Drug: GW05 |
| 5D | Active comparator | Drug: GW05 |
| Metronidazole | Active comparator | Drug: Metronidazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Females at least 18 years of age
- In good general health
- Confirmed current diagnosis of bacterial vaginosis (determined at study screening)
- Negative pregnancy test (for women who are able to become pregnant)
- Must abstain from sexual intercourse throughout the first 7 days of thes study
Key exclusion criteria (4 listed)
- Pregnant, lactating, or planning to become pregnant during the study period
- Menstruating at the time of the diagnosis or anticipate the onset of menses during the treatment phase of the study
- Had a medical event within 90 days of the visit (e.g., stroke, heart attack, etc.)
- Received specific treatments/medications /therapy within the designated time period prior to study enrollment
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 |
|---|---|---|
| GW05vaginal gel once daily regimen A | Drug | 1D |
| GW05vaginal gel once daily regimen B | Drug | 3D |
| GW05vaginal gel once daily regimen C | Drug | 5D |
| Metronidazolevaginal gel 0.75% once daily for 5 days | Drug | Metronidazole |
Primary outcome
proportion of subjects with therapeutic cure
Time frame: day 21 to day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
- Derived from this study: PubMed 24983350Chavoustie SE, Jacobs M, Reisman HA, Waldbaum AS, Levy SF, Hillier SL, Nyirjesy P. Metronidazole vaginal gel 1.3% in the treatment of bacterial vaginosis: a dose-ranging study. J Low Genit Tract Dis. 2015 Apr;19(2):129-34. doi: 10.1097/LGT.0000000000000062.
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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.
Sharon F Levy, MD study director
Graceway Pharmaceuticals
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW05 and Metronidazole in people with Vaginosis, Bacterial and Vaginal Infection, run by Graceway Pharmaceuticals, LLC at 20 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of subjects with therapeutic cure (time frame: day 21 to day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01055106, which also lists 1 linked publication.
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 1 Jul 2011.