Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis

Study Overview
=================
Brief Summary
-----------------
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.

Detailed Description
-----------------
This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.

Official Title
-----------------
A Randomized, Parallel-group Study of Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe

Conditions
-----------------
Vulvovaginal Candidiasis

Intervention / Treatment
-----------------
* Drug: Terconazole Vaginal Suppository
* Drug: Fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7 Subject completes the informed consent process Subject agrees to take study medication when scheduled Subject complies with all clinical trial instructions. Commits to all follow-up visits Subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment Exclusion Criteria: had any other sexually transmitted disease or gynaecological abnormality requiring treatment had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods had used antifungal medication in the week before entry; or were expected to menstruate within seven days of the start of treatment infected more than one candida species

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Terconazole Vaginal Suppository<br>Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days | Drug: Terconazole Vaginal Suppository<br>* Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days<br>* Other names: Tekangzuo Yindao Shuan;|
| Active Comparator: Fluconazole<br>orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4. | Drug: Fluconazole<br>* orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.<br>* Other names: Diflucan;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycological Cure 1 | Based on candida culture | Between day 7-14 after treatment, an average of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycological Cure 2 | Based on Candida culture | Between day 28-35 after treatment, an average of 30 days |