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CTRI Number  CTRI/2010/091/000171 [Registered on: 22/02/2010]
Last Modified On: 08/03/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug 
Study Design  Single Arm Study 
Public Title of Study
Modification(s)  		 A CLINICAL TRIAL TO STUDY THE EFFECTS OF DANAZOL ADMINISTERED VAGINALLY IN WOMEN WITH PELVIC PAIN DUE TO ENDOMETRIOSIS 
Scientific Title of Study
Modification(s)  		 EFFECT OF VAGINAL ADMINISTRATION OF DANAZOL IN PELVIC PAIN DUE TO ENDOMETRIOSIS 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  DRSUDHINDRA MOHAN BHATTACHARYA 
Designation   
Affiliation   
Address  S.C.DAS MEMORIAL MEDICAL AND RESEARCH CENTER
52, JODHPUR PARK
Kolkata
WEST BENGAL
700068
India 
Phone  033-24836330  
Fax    
Email  drsudhindra54@gmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  DRSUDHINDRA MOHAN BHATTACHARYA 
Designation   
Affiliation  CONSULTANT OBSTETRICIAN AND GYNAECOLOGIST 
Address  S.C.DAS MEMORIAL MEDICAL AND RESEARCH CENTER
52, JODHPUR PARK
Kolkata
WEST BENGAL
700068
India 
Phone  033-24836330  
Fax    
Email  drsudhindra54@gmail.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  DRSUDHINDRA MOHAN BHATTACHARYA 
Designation   
Affiliation   
Address  S.C.DAS MEMORIAL MEDICAL AND RESEARCH CENTER
52, JODHPUR PARK
Kolkata
WEST BENGAL
700068
India 
Phone  033-24836330  
Fax    
Email  drsudhindra54@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
NIL 
 
Primary Sponsor
Modification(s)  
Name  DrSMBhattacharya 
Address  flat-4. mohona 5, New Raipur Kolkata- 700084 
Type of Sponsor  Other [Personal endeavour] 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
NIL   
 
Countries of Recruitment
Modification(s)  		   India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DRSUDHINDRA MOHAN BHATTACHARYA  S.C.DAS MEMORIAL MEDICAL AND RESEARCH CENTER  52, JODHPUR PARK,-700068
Kolkata
WEST BENGAL 		 033-24836330

drsudhindra54@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
s.c.das memorial medical and research center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  women with endometriosis having pelvic pain,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  vaginal danazol administration  200 mg daily vaginally for 6 months. 
 
Inclusion Criteria
Modification(s)  
Age From  30.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.pelvic endometriosis (diagnosed by laparoscopy) causing pelvic pain
2.hormone therapies/ laparoscopic cauterisation not giving adequate relief from pain 
 
ExclusionCriteria 
Details  1. pain not due to endometriosis
2.unmarried girls where vaginal administration is not possible. 
 
Method of Generating Random Sequence
Modification(s)  		 Not Applicable 
Method of Concealment
Modification(s)  		 Not Applicable 
Blinding/Masking
Modification(s)  		 Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
RELIEF FROM PELVIC PAIN- ASSESSED WITH VISUAL ANALOG SCALE  FIRST TIME OF ASSESSMENT- 3 MONTHS AFTER STARTING TREATMENT
SECOND TIME OF ASSESSMENT- 6 MONTHS AFTER STARTING TREATMENT 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
CHANGE IN LIVER FUNCTION TEST AND CHANGE IN PLASMA LIPIDS  FIRST TIME OF ASSESSMENT- 3 MONTHS AFTER START OF TREATMENT
SECOND TIME OF ASSESSMENT- 6 MONTHS AFTER START OF TREATMENT 
 
Target Sample Size
Modification(s)  		 Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial
Modification(s)  		 N/A 
Date of First Enrollment (India)
Modification(s)  		 01/11/2009 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Data published-- International Journal Of Gynecology and Obstetrics. doi:10.1016/j.ijgo.2011.06.021 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 WOMEN WITH PELVIC PAIN DUE TO ENDOMETRIOSIS WILL BE TREATED WITH VAGINAL DANAZOL 200 MG DAILY FOR 6 MONTHS. RELIEF FROM PAIN WILL BE ASSESSED WITH VISUAL ANALOG SCALE AND ANY CHANGE IN LIPID PARAMETERS AND LIVER FUNCTION TESTS WILL BE STUDIED AT TWO TIME POINTS- 3 MONTHS AND 6 MONTHS AFTER START OF TREATMENT. 
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