Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TEROV8BAC4001 |
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
Not provided
Not provided
The purpose of this comparative study is to evaluate the efficacy of an ovule with triple active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple active agents (nystatin, metronidazole and fluocinolone) in the treatment of symptoms caused by the presence of vaginitis (inflammation of the vagina) or bacterial vaginosis (polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli).
This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), comparative, parallel (a clinical trial comparing the response in 2 or more groups of participants receiving different treatments) double-arm, multi-center (when more than 1 hospital or medical school team work on a medical research study) study. The study consists of 3 phases: Screening phase on Visit 1 (Day -3/1); Inclusion or treatment phase on Visit 2 (Day 1); and Treatment or monitoring phase (3 days after treatment) on Visit 3 (Day 7 for Gynoclin V and Day 13 for Vagitrol V) and Visit 4 (Day 12 for Gynoclin V and Day 18 for Vagitrol V). Participants will be randomly assigned to 1 of the 2 treatment groups: Gynoclin V and Vagitrol V. Participants in Gynoclin V group will be administered 1 ovule (containing 80 milligram [mg] terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide) vaginally every 24 hours at night, for 3 days. Participants in the Vagitrol V group will be administered 1 ovule (containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin) vaginally every 24 hours at night, for 10 days. Primarily, participants will be evaluated for signs and symptoms, characteristics of vaginal discharge, changes in vulvar region, changes in cervix and presence of bacteria, fungi and/or parasites. Participants' safety will be monitored throughout the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gynoclin V | Experimental | One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days. |
|
| Vagitrol V | Experimental | One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin will be administered vaginally, every 24 hours at night, for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gynoclin V | Drug | One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment. | 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V) |
| Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment. | 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) |
| Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment | Percentage of participants with the presence of microorganisms (Candida albicans, Candida species, Gardnerella vaginalis, Vaginal flora, Lactobacillus species) in the wet mount, KOH, gram stain and vaginal discharge culture (candida and symptomatology) 3 days after treatment. | 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Response to Treatment Assessed by Participant | Response to treatment was evaluated by participant using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag S.A. Clinical Trial | Janssen-Cilag, S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DF | Mexico City | Mexico | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days. |
| FG001 | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vagitrol V | Drug | One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin will be administered vaginally, every 24 hours at night, for 10 days. |
|
| 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) |
| Percentage of Participants With Response to Treatment Assessed by Physician | Response to treatment was evaluated by Physician using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared). | 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) |
| Mexico City |
| Mexico |
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter (mcg/ml) nystatin was administered vaginally, every 24 hours at night, for 10 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in Intent-to-treat (ITT) population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days. |
| BG001 | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days. |
| 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 | Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. A total of 81 participants in Gynoclin V and 78 participants in Vagitrol V were analyzed for this Baseline characteristic. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment. | Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in Intent-to-treat (ITT) population. Here 'N' specifies participants who were evaluated for this outcome measure. | Posted | Number | Percentage of Participants | 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment. | Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure. | Posted | Number | Percentage of Participants | 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment | Percentage of participants with the presence of microorganisms (Candida albicans, Candida species, Gardnerella vaginalis, Vaginal flora, Lactobacillus species) in the wet mount, KOH, gram stain and vaginal discharge culture (candida and symptomatology) 3 days after treatment. | Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' signifies participants who were evaluated for this outcome measure including the participants for whom no culture was performed. | Posted | Number | Percentage of Participants | 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Response to Treatment Assessed by Participant | Response to treatment was evaluated by participant using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared). | Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure. | Posted | Number | Percentage of Participants | 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Response to Treatment Assessed by Physician | Response to treatment was evaluated by Physician using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared). | Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure. | Posted | Number | Percentage of Participants | 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) |
|
Baseline up to Day 13 for Gynoclin V and Day 18 for Vagitrol V
Not provided
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 | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days. | 0 | 81 | 1 | 81 | ||
| EG001 | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days. | 0 | 79 | 1 | 79 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fungal Infections | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Director | Global Clinical Operations Mexico | +52 55 5484 3184 |
| 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
| Male |
|
| Burning: Absent |
|
| Burning: Present |
|
| Sudden vulvar pain: Absent |
|
| Sudden vulvar pain: Present |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|