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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis
The current study is evaluating both the efficacy and safety of the 2 doses of 500 mg clotrimazole vaginal tablet administered intravaginally( at day 1 and day 4) v.s 2 doses of 150 mg fluconazole( at day 1 and day 4) for treatment of severe vulvovaginal candidiasis.The number of participants with adverse events as a measure of safety and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clotrimazole vaginal tablet | Experimental | 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) |
|
| Fluconazole | Active Comparator | 2 doses of 150 mg oral Fluconazole (at day1 and day4) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clotrimazole vaginal tablet | Drug | 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Efficacy 1 | The clinical cure rates of clotrimazole and fluconazol: Clinical cure was defined as the resolution of symptoms present at baseline with a total severity score of ≤2. Improvement was defined as considerable reduction in the severity of baseline signs and symptoms with a decrease in the total score by ≥50%.Patients not clinically cured or showing improvement were considered clinical failures. | 7-14 days after treatment (=visit 2) |
| Therapeutic Efficacy 2 | The clinical cure rates of clotrimazole and fluconazol | at days 30-35 follow-up |
| Therapeutic Efficacy 3 | Mycological cure of clotrimazole group and fluconazole group | at days 7-14 follow-up |
| Therapeutic Efficacy 4 | Mycological cure of clotrimazole group and fluconazole group: Mycological cure or failure was referred to as Candida negative or positive,respectively, on Candida culture at follow-up visits. | at days30-35 follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events 1 | Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue. | at day 7-14 follow up |
| Adverse Events 2 | Vulvovaginal pruritus, burning, irritation, and bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shangrong Fan, M.D. | Peking University Shenzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27073145 | Result | Zhou X, Li T, Fan S, Zhu Y, Liu X, Guo X, Liang Y. The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis. Mycoses. 2016 Jul;59(7):419-28. doi: 10.1111/myc.12485. Epub 2016 Apr 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clotrimazole Vaginal Tablet | 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) |
| FG001 | Fluconazole | 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clotrimazole Vaginal Tablet | 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) |
| BG001 | Fluconazole |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Therapeutic Efficacy 1 | The clinical cure rates of clotrimazole and fluconazol: Clinical cure was defined as the resolution of symptoms present at baseline with a total severity score of ≤2. Improvement was defined as considerable reduction in the severity of baseline signs and symptoms with a decrease in the total score by ≥50%.Patients not clinically cured or showing improvement were considered clinical failures. | PPS | Posted | Number | participants | 7-14 days after treatment (=visit 2) |
|
1 month
The adverse events of clotrimazole vaginal tablet were mainly local and mild. Most of the adverse events of fluconazole were systemic.
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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 | Clotrimazole Vaginal Tablet | 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Systemic | Cardiac disorders | Systematic Assessment | Systemic: weak, palpitation, tachycardia, migraine,headache, dizzy, rhinorrhea, numb, dizziness, fatigue. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shangrong Fan | Peking University | 860755-83923333 | 5502 | fanshangrong@163.com |
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| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003022 | Clotrimazole |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fluconazole | Drug | 2 doses of 150 mg oral Fluconazole (at day1 and day4) |
|
|
| at day 7-14 follow up |
| Adverse Events 3 | Gastrointestinal tract: abdominal pain, diarrhoea, nausea | at day 7-14 follow up |
| Adverse Events 4 | Skin sensitivity, urticaria rash, erythematous rash, irritation | at day 7-14 follow up |
| Total Adverse Events | Total adverse events(cases) | at day 7-14 follow up |
2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4) |
|
|
|
| Primary | Therapeutic Efficacy 2 | The clinical cure rates of clotrimazole and fluconazol | Posted | Number | participants | at days 30-35 follow-up |
|
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| Primary | Therapeutic Efficacy 3 | Mycological cure of clotrimazole group and fluconazole group | Posted | Number | participants | at days 7-14 follow-up |
|
|
|
|
| Primary | Therapeutic Efficacy 4 | Mycological cure of clotrimazole group and fluconazole group: Mycological cure or failure was referred to as Candida negative or positive,respectively, on Candida culture at follow-up visits. | Posted | Number | participants | at days30-35 follow-up |
|
|
|
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| Secondary | Adverse Events 1 | Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue. | Posted | Number | participants | at day 7-14 follow up |
|
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| Secondary | Adverse Events 2 | Vulvovaginal pruritus, burning, irritation, and bleeding | Posted | Number | participants | at day 7-14 follow up |
|
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| Secondary | Adverse Events 3 | Gastrointestinal tract: abdominal pain, diarrhoea, nausea | Posted | Number | participants | at day 7-14 follow up |
|
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| Secondary | Adverse Events 4 | Skin sensitivity, urticaria rash, erythematous rash, irritation | Posted | Number | participants | at day 7-14 follow up |
|
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| Secondary | Total Adverse Events | Total adverse events(cases) | Posted | Number | participants | at day 7-14 follow up |
|
|
|
|
| 0 |
| 115 |
| 13 |
| 115 |
| EG001 | Fluconazole | 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4) | 0 | 113 | 10 | 113 |
|
| Vulvovaginal | Reproductive system and breast disorders | Systematic Assessment | Vulvovaginal pruritus, burning, irritation, and bleeding |
|
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| D014848 |
| Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |
| D014230 |
| Triazoles |