Vulvovaginal Candidiasis
Conditions
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.
Interventions
Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
DRUGFluconazole
orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Sponsors
Shanghai Shyndec Pharmaceutical Co., Ltd.
Peking University Shenzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mycological Cure 1 | Between day 7-14 after treatment, an average of 10 days | Based on candida culture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mycological Cure 2 | Between day 28-35 after treatment, an average of 30 days | Based on Candida culture |
Countries
China
Participant flow
Recruitment details
At Clinic
Participants by arm
| Arm | Count |
|---|---|
| Terconazole Vaginal Suppository Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
Terconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days | 70 |
| Fluconazole Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Fluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4. | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | Terconazole Vaginal Suppository | Fluconazole | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 70 Participants | 140 Participants |
| Sex: Female, Male Female | 70 Participants | 70 Participants | 140 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 70 |
| other Total, other adverse events | 0 / 70 | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
Primary
Mycological Cure 1
Based on candida culture
Time frame: Between day 7-14 after treatment, an average of 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Terconazole Vaginal Suppository | Mycological Cure 1 | 46 Participants |
| Fluconazole | Mycological Cure 1 | 47 Participants |
Secondary
Mycological Cure 2
Based on Candida culture
Time frame: Between day 28-35 after treatment, an average of 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Terconazole Vaginal Suppository | Mycological Cure 2 | 36 Participants |
| Fluconazole | Mycological Cure 2 | 35 Participants |