A clinical trial to study the effect of Fenticonazole Vaginal Capsule in treatment of vaginal candidiasis (fungal infection of female genitals characterized by itching, redness and white discharge).

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/10/005082
• Date of registration: 08-10-2014
• Prospective Registration: Yes
• Primary sponsor: Glenmark Pharmaceuticals Ltd
• Public title: A clinical trial to study the effect of Fenticonazole Vaginal Capsule in treatment of vaginal candidiasis (fungal infection of female genitals characterized by itching, redness and white discharge).
• Scientific title: A Phase III, Multicenter, Single dose, Randomized, Single-Blind, Non-Inferiority, Parallel-Group, Comparative, Study to Evaluate Efficacy and Safety of Fenticonazole vaginal capsule compared to Clotrimazole vaginal tablet in the treatment of Subjects with Vaginal Candidiasis.
• Date of first enrolment: 25-10-2014
• Target sample size: 430
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10190
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Investigator Blinded
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Dr Piyush Agarwal
• Affiliation: Glenmark Pharmaceutical Ltd

• Name: Amol Pendse
• Affiliation: Glenmark Pharmaceutical Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 1. Female subjects age 18 to 65 years.

2. Diagnosis of symptomatic vaginal candidiasis.

3. Presence of vulvovaginal sign as assessed by the investigator at baseline.


Exclusion criteria: 1. Presence of concomitant vaginitis caused by other infections (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis or Neisseria gonorrhoea).

2. Subjects having history of recurrent vaginal candidiasis, defined as occurrence of four or more than four episodes in the previous 12 months.

3. Presence of another vaginal condition that would confound the interpretation of clinical response.

4. Pregnant or lactating women.

5. Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the subjectâ??s ability to safely complete the study.

6. Hypersensitivity to the imidazoles and their analogues or any component of the formulation.

7. History of drug or alcohol dependency or abuse within approximately the last 2 years.

8. Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or scheduled to participate in another clinical study involving an investigational product or investigational drug during the course of this study.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Vaginal Candidiasis (characterized by itching, redness and white discharge from female genitals)

Intervention(s)

Intervention1: Fenticonazole 600 mg vaginal capsule: The dose is 1 capsule intra-vaginal once.
Control Intervention1: Clotrimazole 500 mg vaginal tablet: The dose is 1 tablet intra-vaginal once.

Primary Outcome(s)

Therapeutic cure at the test-of-cure visitTimepoint: Day 8

Secondary Outcome(s)

Therapeutic cure at the end of studyTimepoint: Day 22

Improvement in the composite vulvovaginal signs and symptoms score at the test-of-cure visitTimepoint: Day 8

Secondary ID(s)

GPL/CT/2013/012/III; version 1.0. dated:13 February 2014

Source(s) of Monetary Support

Glenmark Pharmaceuticals Ltd.

Ethics review

Status: Approved
Approval date: 12/05/2014
Contact:

Sanjivani Hospital Ethics Committee

Status: Approved
Approval date: 03/07/2014
Contact:

Institutional Ethics Committee, Institute of Post Graduate Medical Education &Research, Kolkata

Status: Approved
Approval date: 22/07/2014
Contact:

Pentamed Ethics Committee,Medipoint Hospitals Pvt. Ltd., Pune

Status: Approved
Approval date: 13/09/2014
Contact:

Institutional Ethics Committee, Vasavi Medical & Research Centre, Hyderabad

Status: Approved
Approval date: 17/09/2014
Contact:

Institutional Ethics Committee, Dr. B L K Hospital, New Delhi

Status: Approved
Approval date: 24/09/2014
Contact:

Institutional Ethics Committee of B. J. Govt.Medical College and Sasoon General hospitals

Status: Approved
Approval date: 27/11/2014
Contact:

Ethics Committee of SMS Medical College and Attached Hospitals

Status: Approved
Approval date: 05/12/2014
Contact:

Institutional Ethics Committee (IEC) I & II, Seth GS Medical College and KEM Hospital, Mumbai

Status: Approved
Approval date: 21/03/2015
Contact:

Institutional Human Ethics Committee (Institutional Review Board), G.M.E.R.S. Medical College & General Hospital,Vadodara

Status: Approved
Approval date: 06/04/2015
Contact:

Ethics Committee Jehangir Clinical Development Centre Pvt. Ltd, Pune

Status: Approved
Approval date: 11/04/2015
Contact:

Institutional Ethics Committee, , Global Hospital, Hyderabad

Status: Approved
Approval date: 11/04/2015
Contact:

Institutional Ethics Committee, Aware Global Hospital, Hyderabad

Status: Approved
Approval date: 28/04/2015
Contact:

Aster Aadhar Ethics Committee, Kolhapur

Status: Approved
Approval date: 06/05/2015
Contact:

Institutional Ethics Committee on Human Research, Medical College, Baroda

Status: Approved
Approval date: 21/05/2015
Contact:

Institutional Ethics Committee, N.K.P. Salve Institute of Medicine Science & Lata Mangeshkar Hospital, Nagpur

Status: Approved
Approval date: 17/06/2015
Contact:

Institutional Ethics Committee Lokmanya Tilak Municipal Medical College (IEC-HR-LTMMC), Mumbai

Status: Approved
Approval date: 26/06/2015
Contact:

Orange City Hospital Institutional Ethics Committee

Status: Approved
Approval date: 26/06/2015
Contact:

Shree Hospitals Ethics Committee

Status: Approved
Approval date: 25/07/2015
Contact:

Institutional Ethica Committee Om Surgical Center & Maternity Home

Status: Approved
Approval date: 27/07/2015
Contact:

Sapthigiri Institute of Medical Sciences & Research Centre Institutional Ethics Committee

Status: Approved
Approval date: 06/08/2015
Contact:

Ethics Committee, Inamdar Multispeciality Hospital, Pune

Status: Approved
Approval date: 18/08/2015
Contact:

Manipal University Ethics Committee

Status: Approved
Approval date: 18/08/2015
Contact:

Saviour Hospital Ethics Committee

Status: Not Approved
Approval date:
Contact:

Chennai Meenakshi Multispecialty Hospital Ethics Committee

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Santokba Durlabhji Memorial Hospital cum Medical Research Institute, Jaipur

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Sri Ramachandra Medical Center, Chennai

Status: Not Approved
Approval date:
Contact:

Sumana Hospital Ethics Committee

Status: Not Approved
Approval date:
Contact:

The Institutional Ethics Committee-Dept. of Pharmacology, Govt Medical College, Nagpur