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Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

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ClinicalTrials.gov Identifier: NCT02180828
Recruitment Status : Completed
First Posted : July 3, 2014
Results First Posted : September 30, 2016
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Shangrong Fan, Peking University Shenzhen Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Candidiasis, Vulvovaginal
Interventions: Drug: Clotrimazole vaginal tablet
Drug: Fluconazole

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Clotrimazole Vaginal Tablet

2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)

Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)

Fluconazole

2 doses of 150 mg oral Fluconazole (at day1 and day4)

Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)


Participant Flow:   Overall Study
    Clotrimazole Vaginal Tablet   Fluconazole
STARTED   120   120 
COMPLETED   115   113 
NOT COMPLETED   5   7 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Clotrimazole Vaginal Tablet

2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)

Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)

Fluconazole

2 doses of 150 mg oral Fluconazole (at day1 and day4)

Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)

Total Total of all reporting groups

Baseline Measures
   Clotrimazole Vaginal Tablet   Fluconazole   Total 
Overall Participants Analyzed 
[Units: Participants]
 120   120   240 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      120 100.0%      120 100.0%      240 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 29  (6)   29  (7)   29  (7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      120 100.0%      120 100.0%      240 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
China   120   120   240 


  Outcome Measures

1.  Primary:   Therapeutic Efficacy 1   [ Time Frame: 7-14 days after treatment (=visit 2) ]

2.  Primary:   Therapeutic Efficacy 2   [ Time Frame: at days 30-35 follow-up ]

3.  Primary:   Therapeutic Efficacy 3   [ Time Frame: at days 7-14 follow-up ]

4.  Primary:   Therapeutic Efficacy 4   [ Time Frame: at days30-35 follow-up ]

5.  Secondary:   Adverse Events 1   [ Time Frame: at day 7-14 follow up ]

6.  Secondary:   Adverse Events 2   [ Time Frame: at day 7-14 follow up ]

7.  Secondary:   Adverse Events 3   [ Time Frame: at day 7-14 follow up ]

8.  Secondary:   Adverse Events 4   [ Time Frame: at day 7-14 follow up ]

9.  Secondary:   Total Adverse Events   [ Time Frame: at day 7-14 follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Shangrong Fan
Organization: Peking University
phone: 860755-83923333 ext 5502
e-mail: fanshangrong@163.com


Publications of Results:

Responsible Party: Shangrong Fan, Peking University Shenzhen Hospital
ClinicalTrials.gov Identifier: NCT02180828     History of Changes
Other Study ID Numbers: pkuszh-2014-02
First Submitted: June 30, 2014
First Posted: July 3, 2014
Results First Submitted: April 16, 2016
Results First Posted: September 30, 2016
Last Update Posted: May 2, 2017