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The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole gel in the treatment of vaginal infections
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terconazole vaginal gel | Active Comparator | One applicator full at bedtime |
|
| Metronidazole vaginal gel | Active Comparator | One applicator full at bedtime |
|
| Terconazole/metronidazole vaginal gel | Active Comparator | One applicator full at bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terconazole | Drug |
| ||
| Metronidazole |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit | The percentage of participants with clinical cure of both bacterial vaginosis (BV) AND vulvovaginal candidiasis (VVC) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV is defined as: discharge has returned to normal/physiologic, negative whiff test, and saline wet mount is <20% clue cells. Clinical cure of VVC is defined as resolution of all signs and symptoms attributable to vulvovaginal candidiasis | 7-14 days after beginning treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cure of the BV Component of Mixed Infection | The percentage of participants with both BV and VVC who had clinical cure of bacterial vaginosis (BV) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV was 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 |
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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 |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35205 | United States | ||
| University of Alabama |
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| ID | Title | Description |
|---|---|---|
| FG000 | Terconazole Vaginal Gel | One applicator full at bedtime Terconazole |
| FG001 | Metronidazole Vaginal Gel | One applicator full at bedtime Metronidazole |
| 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 22, 2020 |
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|
| Terconazole/metronidazole | Drug |
|
| 7-14 days after beginning treatment |
| Cure of the VVC Component of Mixed Infection | The percentage of participants with both BV and VVC who had clinical cure of VVC was compared between the combination therapy and the two single entity treatments.Clinical cure of VVC was defined as complete resolution of all signs and symptoms attributable to VVC | 7-14 days after beginning treatment |
| Microbiologic and Mycologic Cure | The percentage of participants with both microbiologic and mycologic cure was compared between the combination therapy and the two single entity treatments. Yeast cultures were performed and Gram stains of vaginal fluid were graded according to Nugent's criteria. Microbiologic cure requires normal Nugent gram stain score and mycologic cure requires negative yeast culture. | 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) |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Precision Trials, AZ | Phoenix | Arizona | 85032 | United States |
| MomDoc Womens Health Research | Scottsdale | Arizona | 85251 | United States |
| DelSol Research | Tucson | Arizona | 85710 | 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 |
| Precision Clinical Research | Coral Springs | Florida | 33065 | United States |
| KO Clinical Research, LLC | Fort Lauderdale | Florida | 33316 | United States |
| Segal Institute for Clinical Research | North Miami | Florida | 33161 | United States |
| Discovery Clinical Research | Plantation | Florida | 33324 | United States |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | 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 |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Praetorian Pharmaceutical Research, LLC | Marrero | Louisiana | 70072 | United States |
| Southern Clinical Research Associates | Metairie | Louisiana | 70001 | United States |
| Women Under Study | New Orleans | Louisiana | 70125 | United States |
| Wayne State University | Detroit | Michigan | 48201 | 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 |
| Complete Healthcare for Women | Columbus | Ohio | 43231 | 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 |
| Magnolia Ob/Gyn Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| James T. Martin, MD | North Charleston | South Carolina | 29406 | United States |
| The Jackson Clinic | Jackson | Tennessee | 38305 | United States |
| Discovery Clinical Trials | Dallas | Texas | 75231 | United States |
| Signature Gyn Services | Fort Worth | Texas | 76104 | United States |
| Texas Children's Hospital for Women | Houston | Texas | 77030 | 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 |
| FG002 | Terconazole/Metronidazole Vaginal Gel | One applicator full at bedtime Terconazole/metronidazole |
| 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 and a Baseline visit yeast culture positive for Candida species.
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| ID | Title | Description |
|---|---|---|
| BG000 | Terconazole Vaginal Gel | One applicator full at bedtime Terconazole |
| BG001 | Metronidazole Vaginal Gel | One applicator full at bedtime Metronidazole |
| BG002 | Terconazole/Metronidazole Vaginal Gel | One applicator full at bedtime Terconazole/metronidazole |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| 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 of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit | The percentage of participants with clinical cure of both bacterial vaginosis (BV) AND vulvovaginal candidiasis (VVC) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV is defined as: discharge has returned to normal/physiologic, negative whiff test, and saline wet mount is <20% clue cells. Clinical cure of VVC is defined as resolution of all signs and symptoms attributable to vulvovaginal candidiasis | mITT population (Baseline Nugent Gram stain score of 4 or more, and positive baseline yeast culture, 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 | Cure of the BV Component of Mixed Infection | The percentage of participants with both BV and VVC who had clinical cure of bacterial vaginosis (BV) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV was 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 Nugent Gram stain score of 4 or more, and positive baseline yeast culture, 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 | Cure of the VVC Component of Mixed Infection | The percentage of participants with both BV and VVC who had clinical cure of VVC was compared between the combination therapy and the two single entity treatments.Clinical cure of VVC was defined as complete resolution of all signs and symptoms attributable to VVC | mITT population (Baseline Nugent Gram stain score of 4 or more, and positive baseline yeast culture, 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 and Mycologic Cure | The percentage of participants with both microbiologic and mycologic cure was compared between the combination therapy and the two single entity treatments. Yeast cultures were performed and Gram stains of vaginal fluid were graded according to Nugent's criteria. Microbiologic cure requires normal Nugent gram stain score and mycologic cure requires negative yeast culture. | mITT population (Baseline Nugent Gram stain score of 4 or more, and positive baseline yeast culture, 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 Nugent Gram stain score of 4 or more, and positive baseline yeast culture, 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 | Safety population, defined as 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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The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a negative yeast culture and/or normal gram stain at the baseline visit. 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.
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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 | Terconazole Vaginal Gel | One applicator full at bedtime Terconazole | 0 | 149 | 1 | 149 | 5 | 149 |
| EG001 | Metronidazole Vaginal Gel | One applicator full at bedtime Metronidazole | 0 | 151 | 0 | 151 | 6 | 151 |
| EG002 | Terconazole/Metronidazole Vaginal Gel | One applicator full at bedtime Terconazole/metronidazole | 0 | 154 | 0 | 154 | 8 | 154 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vulvovaginal burning sensation | Reproductive system and breast 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 Curatek confidential information, Investigator shall submit to Curatek 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 Curatek.
| 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 22, 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 |
|---|---|
| C037815 | terconazole |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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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| Superiority |
| Stratified by race (black, white, or other race) | Cochran-Mantel-Haenszel | 0.0204 | Superiority |
| Stratified by race (black, white, or other race) | Cochran-Mantel-Haenszel | 0.0493 | Superiority |
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| Participants |
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| Participants |
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