Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Terconazole Vaginal Suppository Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days |
Drug: Terconazole Vaginal Suppository
Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
Other Names:
|
Active Comparator: Fluconazole orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4. |
Drug: Fluconazole
orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mycological Cure 1 [Between day 7-14 after treatment, an average of 10 days]
Based on candida culture
Secondary Outcome Measures
- Mycological Cure 2 [Between day 28-35 after treatment, an average of 30 days]
Based on Candida culture
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Peking University Shenzhen Hosptal | Shenzhen | Guangdong | China | 518036 |
Sponsors and Collaborators
- Peking University Shenzhen Hospital
- Shanghai Shyndec Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Shangrong Fan, M.D., Peking University Shenzhen Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
- Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
Publications
None provided.- PKUSH-GNY-2013-01
Study Results
Participant Flow
Recruitment Details | At Clinic |
---|---|
Pre-assignment Detail |
Arm/Group Title | Terconazole Vaginal Suppository | Fluconazole |
---|---|---|
Arm/Group Description | 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 | 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. |
Period Title: Overall Study | ||
STARTED | 70 | 70 |
COMPLETED | 58 | 66 |
NOT COMPLETED | 12 | 4 |
Baseline Characteristics
Arm/Group Title | Terconazole Vaginal Suppository | Fluconazole | Total |
---|---|---|---|
Arm/Group Description | 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 | 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. | Total of all reporting groups |
Overall Participants | 70 | 70 | 140 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
70
100%
|
70
100%
|
140
100%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
Sex: Female, Male (Count of Participants) | |||
Female |
70
100%
|
70
100%
|
140
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
Title | Mycological Cure 1 |
---|---|
Description | Based on candida culture |
Time Frame | Between day 7-14 after treatment, an average of 10 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Terconazole Vaginal Suppository | Fluconazole |
---|---|---|
Arm/Group Description | 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 | 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. |
Measure Participants | 58 | 66 |
Count of Participants [Participants] |
46
65.7%
|
47
67.1%
|
Title | Mycological Cure 2 |
---|---|
Description | Based on Candida culture |
Time Frame | Between day 28-35 after treatment, an average of 30 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Terconazole Vaginal Suppository | Fluconazole |
---|---|---|
Arm/Group Description | 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 | 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. |
Measure Participants | 58 | 66 |
Count of Participants [Participants] |
36
51.4%
|
35
50%
|
Adverse Events
Time Frame | Day 35 after treatment | |||
---|---|---|---|---|
Adverse Event Reporting Description | Vulvovaginal pruritus, burning and irritation | |||
Arm/Group Title | Terconazole Vaginal Suppository | Fluconazole | ||
Arm/Group Description | 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 | 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. | ||
All Cause Mortality |
||||
Terconazole Vaginal Suppository | Fluconazole | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/70 (0%) | 0/70 (0%) | ||
Serious Adverse Events |
||||
Terconazole Vaginal Suppository | Fluconazole | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/70 (0%) | 0/70 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Terconazole Vaginal Suppository | Fluconazole | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/70 (0%) | 0/70 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Prof. Shangrong Fan |
---|---|
Organization | Peking University Shenzhen Hospital |
Phone | 86755-83923333 ext 5502 |
fanshangrong@163.com |
- PKUSH-GNY-2013-01