Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the treatment of vaginal infections
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terconazole vaginal gel | Active Comparator | One applicator full at bedtime |
|
| Gel vehicle | Placebo Comparator | One applicator full at bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terconazole | Drug |
| ||
| Placebo |
| 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. A clinical cure is defined as the resolution of all signs and symptoms attributable to vulvovaginal candidiasis | 7-14 days after beginning treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection | Signs (edema, erythema, excoriation) and symptoms (itching, burning irritation) were each scored as absent (0), mild (1), moderate (2) or severe (3). A total sign score of 0-9 and total symptom score of 0-9 were combined for a total possible combined sign and symptom score of 0-18. Total median combined sign and symptom severity score was compared between arms at the test of cure visit. Lower scores at day 7-14 indicate improvement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | ||
| New Horizons Clinical Trials |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Terconazole Vaginal Gel | One applicator full at bedtime Terconazole |
| FG001 | Gel Vehicle | One applicator full at bedtime Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 7-14 days after beginning treatment |
| Mycologic Cure | Vaginal swabs were cultured for Candida species in a laboratory. A positive culture indicates presence of vaginal yeast and a negative culture indicates absence of vaginal yeast. A negative culture indicates mycologic cure. | 7-14 days after beginning treatment and at 21-30 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) |
| Chandler |
| Arizona |
| 85224 |
| United States |
| MomDoc Womens Health Research | 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 |
| 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 |
| 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 |
| Praetorian Pharmaceutical Research, LLC | Marrero | Louisiana | 70072 | United States |
| Southern Clinical Research Associates | Metairie | Louisiana | 70001 | 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 |
| HWC Women's Research Center | Englewood | Ohio | 45322 | 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 |
| Discovery Clinical Trials | Dallas | Texas | 75231 | United States |
| TMC Life Research, Inc. | Houston | Texas | 77054 | United States |
| Multicare Women's Center Covington | Covington | Washington | 98042 | United States |
| Women's Clinical Research Center | Seattle | Washington | 98105 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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 positive baseline vaginal fungal culture for Candida species.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Terconazole Vaginal Gel | One applicator full at bedtime Terconazole |
| BG001 | Gel Vehicle | One applicator full at bedtime Placebo |
| BG002 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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. A clinical cure is defined as the resolution of all signs and symptoms attributable to vulvovaginal candidiasis | mITT population (positive baseline yeast culture and used at least one dose of study medication) | Posted | Count of Participants | Participants | 7-14 days after beginning treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection | Signs (edema, erythema, excoriation) and symptoms (itching, burning irritation) were each scored as absent (0), mild (1), moderate (2) or severe (3). A total sign score of 0-9 and total symptom score of 0-9 were combined for a total possible combined sign and symptom score of 0-18. Total median combined sign and symptom severity score was compared between arms at the test of cure visit. Lower scores at day 7-14 indicate improvement. | mITT population (positive baseline yeast culture and used at least one dose of study medication) | Posted | Median | Full Range | score on a scale | 7-14 days after beginning treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mycologic Cure | Vaginal swabs were cultured for Candida species in a laboratory. A positive culture indicates presence of vaginal yeast and a negative culture indicates absence of vaginal yeast. A negative culture indicates mycologic cure. | mITT population (positive baseline yeast culture and used at least one dose of study medication) | Posted | Count of Participants | Participants | 7-14 days after beginning treatment and at 21-30 days after beginning treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 (positive baseline yeast culture and used at least one dose of study medication) | Posted | Count of Participants | Participants | 7-14 days after beginning treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) |
|
|
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 negative yeast culture at the baseline visit.
Not provided
| 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 | 102 | 0 | 102 | 16 | 102 |
| EG001 | Gel Vehicle | One applicator full at bedtime Placebo | 0 | 99 | 0 | 99 | 14 | 99 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C037815 | terconazole |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
| Culture not taken |
|