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| Name | Class |
|---|---|
| Mahidol University | OTHER |
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A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in patients suffering from vulvovaginal candidiasis, to assess safety of the two medications during the treatment, and to evaluate women's satisfaction with the two treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluomizin vaginal tablets | Experimental | Fluomizin vaginal tablets containing 10mg dequalinium chloride once daily for 6 days and one placebo vaginal tablet on day 7 |
|
| Canesten vaginal tablets | Active Comparator | Canesten vaginal tablets containing 100mg clotrimazole once daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluomizin vaginal tablets | Drug | One vaginal tablet for 6 days and 1 placebo tablet on day 7 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate | Clinical cure rate is defined as Total Severity Score (TSC) ≤ 2 | Control 1 at day 4 after therapy end |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological cure rate | Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture | Control 1 at 4 days after therapy end |
| Therapeutic cure rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manopchai Thamkhantho, Prof MD | Siriraj Gynaecologic ID and Female STD Unit, Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Gynaecologic ID and Female STD Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok | Bangkok Noi District | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32940765 | Derived | Thamkhantho M, Chayachinda C. Vaginal tablets of dequalinium chloride 10 mg versus clotrimazole 100 mg for vaginal candidiasis: a double-blind, randomized study. Arch Gynecol Obstet. 2021 Jan;303(1):151-160. doi: 10.1007/s00404-020-05784-z. Epub 2020 Sep 17. |
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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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| Canesten vaginal tablets | Drug | one vaginal tablet for 7 days |
|
|
Clinically and microbiologically cured
| Control 1 at 4 days after therapy end |
| Individual clinical signs and symptoms | 4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation | Control 1 at 4 days after therapy end |
| Presence of dyspareunia | yes/no | Control 1 at 4 days after therapy end |
| Direct microscopy (wet smear) | Presence or absence of Candida hyphea or spores | Control 1 at 4 days after therapy end |
| vaginal pH | Control 1 at 4 days after therapy end |
| Candida culture | positive / negative for Candida spp | Control 1 at 4 days after therapy end |
| Global assessment of efficacy | 4-point rating scale assessed by investigator and patient | Control 1 at 4 days after therapy end |
| Patient Satisfaction | presence of vaginal discomfort, increased discharge, burning sensation | Control 1 at 4 days after therapy end |
| Adverse event | Number of participants experiencing an adverse event | Control 1 at 4 days after therapy end |
| Global assessment of tolerability | 4-point rating scale by investigator and patient | Control 1 at 4 days after therapy end |
| Clinical cure rate | Clinical cure rate defined as Total Symptom Score TSC ≤ 2 | Control 2 at 6 weeks after therapy end |
| Presence of external dysuria | yes/no | Control 1 at 4 days after therapy end |
| Microbiological cure rate | Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture | Control 2 at 6 weeks after therapy end |
| Therapeutic cure rate | Clinically and microbiologically cured | Control 2 at 6 weeks after therapy end |
| Individual clinical signs and symptoms | 4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation | Control 2 at 6 weeks after therapy end |
| Presence of dyspareunia | yes/no | Control 2 at 6 weeks after therapy end |
| Direct microscopy (wet smear) | Presence or absence of Candida hyphea or spores | Control 2 at 6 weeks after therapy end |
| vaginal pH | Control 2 at 6 weeks after therapy end |
| Candida culture | positive / negative for Candida spp | Control 2 at 6 weeks after therapy end |
| Global assessment of efficacy | 4-point rating scale assessed by investigator and patient | Control 2 at 6 weeks after therapy end |
| Patient Satisfaction | presence of vaginal discomfort, increased discharge, burning sensation | Control 2 at 6 weeks after therapy end |
| Adverse event | Number of participants experiencing an adverse event | Control 2 at 6 weeks after therapy end |
| Global assessment of tolerability | 4-point rating scale by investigator and patient | Control 2 at 6 weeks after therapy end |
| Presence of external dysuria | yes/no | Control 2 at 6 weeks after therapy end |
| 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 |