Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis
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| ClinicalTrials.gov Identifier: NCT01055106 |
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Recruitment Status :
Completed
First Posted : January 25, 2010
Last Update Posted : July 1, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vaginosis, Bacterial Vaginal Infection | Drug: GW05 Drug: Metronidazole | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 255 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Investigator-Blinded, Phase 2, Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis |
| Study Start Date : | January 2010 |
| Actual Primary Completion Date : | April 2010 |
| Actual Study Completion Date : | April 2010 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: 1D |
Drug: GW05
vaginal gel once daily regimen A
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| Active Comparator: 3D |
Drug: GW05
vaginal gel once daily regimen B
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| Active Comparator: 5D |
Drug: GW05
vaginal gel once daily regimen C
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| Active Comparator: Metronidazole |
Drug: Metronidazole
vaginal gel 0.75% once daily for 5 days
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- proportion of subjects with therapeutic cure [ Time Frame: day 21 to day 30 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055106
| United States, Arizona | |
| Women's Health Research | |
| Phoenix, Arizona, United States, 85015 | |
| Precision Trials | |
| Phoenix, Arizona, United States, 85032 | |
| United States, Arkansas | |
| NEA Women's Clinic | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| Women's Health Center Inc | |
| San Diego, California, United States, 92123 | |
| United States, Colorado | |
| Downtown Women's Healthcare | |
| Denver, Colorado, United States, 80218 | |
| United States, Florida | |
| Miami Research Associates | |
| Miami, Florida, United States, 33143 | |
| Segal Institiute for Clinical Research | |
| North Miami, Florida, United States, 33161 | |
| All Women's Healthcare of West Broward | |
| Plantation, Florida, United States, 33324 | |
| United States, Georgia | |
| Atlanta North Gynecology | |
| Roswell, Georgia, United States, 30075 | |
| United States, Illinois | |
| Women's Health Practice | |
| Champaign, Illinois, United States, 61820 | |
| United States, Massachusetts | |
| ActivMed Practices & Research | |
| Haverhill, Massachusetts, United States, 01830 | |
| United States, Michigan | |
| Grand Rapids Women's Health | |
| Grand Rapids, Michigan, United States, 49503 | |
| Saginaw Valley Medical Research Group | |
| Saginaw, Michigan, United States, 48604 | |
| United States, New Jersey | |
| Women's Health Research Center | |
| Plainsboro, New Jersey, United States, 08536 | |
| United States, Pennsylvania | |
| Drexel University College of Medicine | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| United States, Tennessee | |
| Jackson Clinic | |
| Jackson, Tennessee, United States, 38305 | |
| Adams Patterson OBGYN | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Women's Partners in Health | |
| Austin, Texas, United States, 78705 | |
| TMC Life Research | |
| Houston, Texas, United States, 77054 | |
| United States, Virginia | |
| Tidewater Physicians for Women | |
| Norfolk, Virginia, United States, 23502 | |
| Study Director: | Sharon F Levy, MD | Graceway Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sharon F. Levy, MD / Vice President Product Develpoment, Graceway Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01055106 History of Changes |
| Other Study ID Numbers: |
GW05-0904 |
| First Posted: | January 25, 2010 Key Record Dates |
| Last Update Posted: | July 1, 2011 |
| Last Verified: | June 2011 |
Keywords provided by Graceway Pharmaceuticals, LLC:
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bacterial vaginosis vaginal infection vaginal discharge vaginal disease |
Additional relevant MeSH terms:
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Vaginal Diseases Vaginosis, Bacterial Genital Diseases, Female Bacterial Infections Vaginitis |
Metronidazole Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents |