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CTRI Number  CTRI/2020/05/025130 [Registered on: 12/05/2020] Trial Registered Prospectively
Last Modified On: 04/05/2020
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A study to find out the most effective dose of a medicine to treat fungal infections (Itraconazole).  
Scientific Title of Study   Itraconazole in acute vulvovaginal candidiasis (VVC): a dose finding study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Piyush Prabhat  
Designation  Consultant Gynaecologist 
Affiliation  Jeevak hospital 
Address  Department of Gynecology, Room no 5, Sai Kunj opp Dadar fire brigade station Dr Baba Saheb Ambedkar Rd Dadar East Mumbai Maharashtra

Mumbai
MAHARASHTRA
400014
India 
Phone    
Fax    
Email  drpiyushprabhat@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Piyush Prabhat  
Designation  Consultant Gynaecologist 
Affiliation  Jeevak hospital 
Address  Department of Gynecology, Room no 5, Sai Kunj opp Dadar fire brigade station Dr Baba Saheb Ambedkar Rd Dadar East Mumbai Maharashtra

Mumbai
MAHARASHTRA
400014
India 
Phone    
Fax    
Email  drpiyushprabhat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Piyush Prabhat  
Designation  Consultant Gynaecologist 
Affiliation  Jeevak hospital 
Address  Department of Gynecology, Room no 5, Sai Kunj opp Dadar fire brigade station Dr Baba Saheb Ambedkar Rd Dadar East Mumbai Maharashtra

Mumbai
MAHARASHTRA
400014
India 
Phone    
Fax    
Email  drpiyushprabhat@gmail.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Limited Glenmark House BD Sawant Marg Andheri East Mumbai 400099 
 
Primary Sponsor  
Name  Jeevak hospital  
Address  Dadar fire brigade station, Dr Baba Saheb Ambedkar Rd, Dadar East, Mumbai, Maharashtra  
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Piyush Prabhat   Jeevak hospital   Department of Gynecology, Room no. 5, Sai Kunj opp Dadar fire brigade station, Dr Baba Saheb Ambedkar Rd, Dadar East, Mumbai, Maharashtra, Pin-code - 400014
Mumbai
MAHARASHTRA 		 9821043763

drpiyushprabhat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Suraksha Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B373||Candidiasis of vulva and vagina,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Itraconazole and Fenticonazole  Itraconazole - Dosage Form: Capsule Dosage: 100 mg Dosage Frequency: 2 capsules twice daily for 2 days administered orally Fenticonazole - Dosage Form: Ovule Dosage: 600 mg Dosage Frequency: single dose on day 1. Mode of Administration: Intravaginal 
Intervention  Itraconazole and Fenticonazole  Itraconazole - Dosage Form: Capsule Dosage: 100 mg Dosage Frequency: 2 capsules twice daily for 1 day administered orally Fenticonazole - Dosage Form: Ovule Dosage: 600 mg Dosage Frequency: single dose on day 1. Mode of Administration: Intravaginal 
Intervention  Itraconazole and Fenticonazole  Itraconazole - Dosage Form: Capsule Dosage: 100 mg Dosage Frequency: 2 capsules twice daily for 3 days administered orally Fenticonazole - Dosage Form: Ovule Dosage: 600 mg Dosage Frequency: single dose on day 1. Mode of Administration: Intravaginal 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  - Patients aged ≥ 18 years and ≤ 60 years.
- Patients with acute vulvovaginal candidiasis (VVC) diagnosed clinically by presence of curdy white vaginal discharge.
- Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol, among others a negative urine pregnancy test in the case of women of childbearing age.
- Patients who the study staff deems reliable and mentally competent to carry out the study. 
 
ExclusionCriteria 
Details  - Pregnant or nursing females.
- Patients with chronic or recurrent VVC.
- Patients who have received systemic or intravaginal antifungal treatment in the past 1 month.
- Patients with concurrent bacterial, viral or trichomonal vaginal infection.
- Patients with known hypersensitivity to the study drugs.
- Patients with immunosuppressive disease or on immunosuppressive drugs.
- Patients with liver dysfunction.
- Patients with a history of seizures
- Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject’s safety or interfere with the study assessments.
- Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subject’s ability to safely complete the study.
- History of drug or alcohol dependency or abuse within approximately the last 2 years.
- Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study.
- Any patient whom the investigator judged to be inappropriate for this study. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary effectiveness endpoint will be percentage of patients achieving clinical cure. (Clinical cure is defined as clear or almost clear symptoms [abnormal vaginal discharge, itching, redness, dysuria, dyspareunia]   Day 1 and Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in each symptom and sign from baseline in each visit, which will include physician as well as patient’s assessment of these signs and symptoms.  Day 1 and Day 7 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   15/05/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is an open label, prospective, randomized, dose finding, three arm, single-center clinical trial.Once the patient satisfies the inclusion criteria, she would be treated with itraconazole and fenticonazole as per the dosing schedule. Patients will be randomized to receive one of the treatments: Group I (n=35): Itraconazole 100 mg 2 capsules twice daily for 1 day + intravaginal fenticonazole 600 mg single dose on day 1., Group II (n=35): Itraconazole 100 mg 2 capsules twice daily for 2 days + intravaginal fenticonazole 600 mg single dose on day 1., Group III (n=35): Itraconazole 100 mg 1 capsules twice daily for 3 days + intravaginal fenticonazole 600 mg single dose on day 1. The patients would be called for regular follow up as per the schedule. Primary endpoint will be assessed for percentage of patients achieving clinical cure in each regime for all the groups and Improvement in each symptom and sign from baseline and each visit will be monitored as secondary parameter in all the groups. Even safety (incidences of treatment emergent adverse events (TEAEs)) will be checked throughout the study. 
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