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
Not provided
Not provided
This study is a multicenter, randomized, double-blind, active-controlled, dose-ranging clinical trial designed to evaluate the efficacy and safety of the investigational drug compared to the active comparator in the treatment of vulvovaginal candidiasis. The trial consists of three phases: screening/enrollment (D-3 to D-1), treatment period (D1 to D3), and follow-up period (D4, D11±2, D25±3). Eligible subjects in this study will be randomized in a 1:1:1:1 ratio to three investigational drug arms with different dosing regimens and one active control arm. Specifically, Group A will receive WXSH0102 tablets with 1400 mg on the first day followed by a maintenance dose of 700 mg for two consecutive days, Group B will receive WXSH0102 tablets with 1000 mg on the first day followed by a maintenance dose of 500 mg for two consecutive days, Group C will receive WXSH0102 tablets with 600 mg on the first day followed by a maintenance dose of 300 mg for two consecutive days, and Group D (active control group) will receive fluconazole capsules for only one day on D1. All medications will be administered orally.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A : WXSH0102 Day1 1400 mg Day2-3 700 | Experimental | Arm A will receive WXSH0102 tablets with a loading dose of 1400 mg on the first day followed by a maintenance dose of 700 mg for two consecutive days |
|
| Arm B : WXSH0102 Day1 1000 mg Day2-3 500 arm | Experimental | Arm B will receive WXSH0102 tablets with a loading dose of 1000 mg on the first day followed by a maintenance dose of 500 mg for two consecutive days |
|
| C : WXSH0102 Day1 600 mg Day2-3 300 | Experimental | Arm C will receive WXSH0102 tablets with a loading dose of 600 mg on the first day followed by a maintenance dose of 300 mg for two consecutive days |
|
| Arm D: fluconazole | Active Comparator | Arm D (active control group) will receive fluconazole capsules for only one day on D1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WXSH0102/placebo | Drug | Administer WXSH0102 tablets/placebo orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving cure at the D11±2 visit. | Proportion of subjects achieving cure (defined as the disappearance of VVC symptoms and signs along with a negative Candida culture) at the D11±2 visit. | day 11±2 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving clinical cure at the D11±2 visit | Proportion of subjects achieving clinical cure (complete disappearance of VVC symptoms and signs) at the D11±2 visit; | day 11±2 |
| Proportion of subjects achieving mycological clearance at the D11±2 visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaohui Liu, professor | Contact | 13701118639 | 23662161@qq.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 251 Yaojiayuan Road, Chaoyang District, Beijing | Not yet recruiting | Beijing | Beijing Municipality | 100025 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| fluconazole capsules/placebo | Drug | Administer fluconazole capsules/placebo orally |
|
Proportion of subjects achieving mycological clearance (negative growth of Candida species in fungal culture) at the D11±2 visit; |
| day 11±2 |
| Proportion of subjects achieving clinical improvement at the D11±2 visit | Proportion of subjects achieving clinical improvement (partial or complete resolution of symptoms and signs, with a total VVC scale score ≤1) at the D11±2 visit | day 11±2 |
| Difference in VVC scale scores between the D11±2 visit and baseline visit | Difference in VVC scale scores between the D11±2 visit and baseline visit | day 11±2 |
| Proportion of subjects achieving cure at the D25±3 visit. | Proportion of subjects achieving cure (defined as the disappearance of VVC symptoms and signs along with a negative Candida culture) at the D25±3 visit.. | Day 25±3 |
| Proportion of subjects achieving mycological clearance at the D25±3 visit | Description: Proportion of subjects achieving mycological clearance (negative growth of Candida species in fungal culture) at the D25±3 visit; | Day 25±3 |
| Proportion of subjects achieving clinical improvement at the D25±3 visit | Description: Proportion of subjects achieving clinical improvement (partial or complete resolution of symptoms and signs, with a total VVC scale score ≤1) at the D25±3visit | Day 25±3 |
| Proportion of subjects requiring rescue therapy during the trial; | Proportion of subjects requiring rescue therapy during the trial; | Day 25±3 |
| Proportion of subjects with normal vaginal microecology assessments | Proportion of subjects with normal vaginal microecology assessments at the D11±2 and D25±3 visits | Day11±2 and day 25±3 |
| adverse events | Incidence and severity of adverse events and serious adverse events | Day 25±3 |
| AUC0-tau | the AUC0-tau estimated using non-compartmental and/or population pharmacokinetic models | day 4 |
| Cmax | the Cmax estimated using non-compartmental and/or population pharmacokinetic models | day 4 |
| Beijing Obstetrics and Gynecology Hospital | Recruiting | Beijing | Beijing Municipality | 100025 | China |
|
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |