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

Sponsor
Peking University Shenzhen Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02180100
Collaborator
Shanghai Shyndec Pharmaceutical Co., Ltd. (Industry)
140
1
2
10
14

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

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Parallel-group Study of Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

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:
  • Tekangzuo Yindao Shuan
  • 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:
  • Diflucan
  • Outcome Measures

    Primary Outcome Measures

    1. Mycological Cure 1 [Between day 7-14 after treatment, an average of 10 days]

      Based on candida culture

    Secondary Outcome Measures

    1. Mycological Cure 2 [Between day 28-35 after treatment, an average of 30 days]

      Based on Candida culture

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 48 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    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:

    Publications

    None provided.
    Responsible Party:
    Shangrong Fan, Prof of Obstetrics and Gynecology, Peking University Shenzhen Hospital
    ClinicalTrials.gov Identifier:
    NCT02180100
    Other Study ID Numbers:
    • PKUSH-GNY-2013-01
    First Posted:
    Jul 2, 2014
    Last Update Posted:
    Oct 23, 2020
    Last Verified:
    Oct 1, 2020

    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

    1. Primary Outcome
    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%
    2. Secondary Outcome
    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

    [Not Specified]

    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
    Email fanshangrong@163.com
    Responsible Party:
    Shangrong Fan, Prof of Obstetrics and Gynecology, Peking University Shenzhen Hospital
    ClinicalTrials.gov Identifier:
    NCT02180100
    Other Study ID Numbers:
    • PKUSH-GNY-2013-01
    First Posted:
    Jul 2, 2014
    Last Update Posted:
    Oct 23, 2020
    Last Verified:
    Oct 1, 2020