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The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronidazole vaginal gel | Active Comparator | One applicator full at bedtime |
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| Gel vehicle | Placebo Comparator | One applicator full at bedtime |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole | Drug |
| ||
| Gel vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit | The percentage of participants with clinical cure in each arm was compared. Clinical cure of bacterial vaginosis is defined as 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine "fishy" odor, 3. the saline wet mount is <20% clue cells | 7-14 days after beginning treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of BV Clue Cells | Clue cells on wet mount were assessed and categorized as absent (<20%) or present (>=20%). Absence of clue cells is associated with improvement. The comparison was for percentage between arms for clue cells absent (<20%). | 7-14 days after beginning treatment |
| Microbiologic Improvement/Cure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Borgman, Ph.D. | Curatek Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| MomDoc Womens Health Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metronidazole Vaginal Gel | One applicator full at bedtime Metronidazole |
| FG001 | Gel Vehicle | One applicator full at bedtime Gel vehicle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 12, 2015 | Jun 18, 2020 |
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For bacterial vaginosis (BV), Gram stain Nugent scores are catergized as normal (0 to 3), intermediate (4 to 6) or BV (7 to 10). Normal scores are associated with BV microbiologic cure. The percentage of participants with normal scores were compared between treatments. |
| 7-14 days after beginning treatment |
| Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit | Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms. | 7-14 days after beginning treatment |
| Number of Participants With Treatment Emergent Adverse Events | Adverse events were collected at study visits, from subject diaries and from spontaneous reports | Any time during study participation (up to 30 days) |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| NEA Baptist Clinic | Jonesboro | Arkansas | 72401 | United States |
| Gossmont Center for Clinical Research | La Mesa | California | 91942 | United States |
| Genesis Center for Clinical Research | San Diego | California | 92103 | United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| Downtown Women's Health Care | Denver | Colorado | 80209 | United States |
| Red Rocks Ob/Gyn | Lakewood | Colorado | 80228 | United States |
| Women's Health CT Ob/Gyn | Bridgeport | Connecticut | 06606 | United States |
| Segal Institute for Clinical Research | North Miami | Florida | 33161 | United States |
| Discovery Clinical Research | Plantation | Florida | 33324 | United States |
| Georgia Regents University | Augusta | Georgia | 30912 | United States |
| Atlanta North Gynecology | Roswell | Georgia | 30075 | United States |
| Mount Vernon CLinical Research | Sandy Springs | Georgia | 30328 | United States |
| Rosemark Womens Care Specialists | Idaho Falls | Idaho | 83404 | United States |
| Women's Health Practice | Champaign | Illinois | 61802 | United States |
| Women's Healthcare Specialists, PC | Kalamazoo | Michigan | 49009 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Women's Clinic of Lincoln | Lincoln | Nebraska | 68510 | United States |
| Legacy Women's Health | Las Vegas | Nevada | 89123 | United States |
| R. Garn Mabey Jr., MD Gynecology | Las Vegas | Nevada | 89128 | United States |
| Lawrence Ob/Gyn Clinical Research LLC | Lawrenceville | New Jersey | 08648 | United States |
| Women's Health Research Center | Plainsboro | New Jersey | 08536 | United States |
| Suffolk OB/GYN | Port Jefferson | New York | 11777 | United States |
| East Carolina Women's Center | New Bern | North Carolina | 28562 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Radiant Research | Columbus | Ohio | 43212 | United States |
| Drexel University | Philadelphia | Pennsylvania | 19102 | United States |
| Philapelphia Clinical Research, LLC | Philadelphia | Pennsylvania | 19114 | United States |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| James T. Martin, MD | North Charleston | South Carolina | 29406 | United States |
| The Jackson Clinic | Jackson | Tennessee | 38305 | United States |
| TMC Life Research, Inc. | Houston | Texas | 77054 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Women's Clinical Research Center | Seattle | Washington | 98105 | United States |
| COMPLETED |
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| NOT COMPLETED |
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modified intent-to-treat (mITT) population includes all subjects randomized to treatment and administered at least one dose of study drug. In addition, subjects must have a Nugent score of 4 or more on Baseline visit Gram stain slide.
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| ID | Title | Description |
|---|---|---|
| BG000 | Metronidazole Vaginal Gel | One applicator full at bedtime Metronidazole |
| BG001 | Gel Vehicle | One applicator full at bedtime Gel vehicle |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit | The percentage of participants with clinical cure in each arm was compared. Clinical cure of bacterial vaginosis is defined as 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine "fishy" odor, 3. the saline wet mount is <20% clue cells | mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication) | Posted | Count of Participants | Participants | 7-14 days after beginning treatment |
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| Secondary | Improvement of BV Clue Cells | Clue cells on wet mount were assessed and categorized as absent (<20%) or present (>=20%). Absence of clue cells is associated with improvement. The comparison was for percentage between arms for clue cells absent (<20%). | mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication) | Posted | Count of Participants | Participants | 7-14 days after beginning treatment |
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| Secondary | Microbiologic Improvement/Cure | For bacterial vaginosis (BV), Gram stain Nugent scores are catergized as normal (0 to 3), intermediate (4 to 6) or BV (7 to 10). Normal scores are associated with BV microbiologic cure. The percentage of participants with normal scores were compared between treatments. | mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication) | Posted | Count of Participants | Participants | 7-14 days after beginning treatment |
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| Secondary | Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit | Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms. | mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication) | Posted | Count of Participants | Participants | 7-14 days after beginning treatment |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events | Adverse events were collected at study visits, from subject diaries and from spontaneous reports | The safety population includes all subjects randomized to treatment and administered at least one dose of study drug. | Posted | Count of Participants | Participants | Any time during study participation (up to 30 days) |
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Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment).
Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting. The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a normal gram stain Nugent score at the baseline visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metronidazole Vaginal Gel | One applicator full at bedtime Metronidazole | 0 | 96 | 0 | 96 | 25 | 96 |
| EG001 | Gel Vehicle | One applicator full at bedtime Gel vehicle | 0 | 97 | 0 | 97 | 10 | 97 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vulvovaginal pruritis | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
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| Vulvovaginal candidiasis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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Investigators have the right to disclose and publish results of the Study conducted by them; provided that, in order to protect any Sponsor confidential information, Investigator shall submit to Sponsor manuscripts at least 30 days before submission for publication or 10 days before public presentation. After that time, Investigator is free to submit the manuscript for publication or deliver the presentation, provided Investigator removes any confidential information as directed by Sponsor
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President | Curatek Pharmaceuticals | 847-806-7680 | info@curatek.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2018 | Jun 18, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| D005782 | Gels |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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