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CTRI Number  CTRI/2020/10/028556 [Registered on: 22/10/2020] Trial Registered Prospectively
Last Modified On: 09/02/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A study to evaluate the safety and efficacy of Dienogest in patients suffering from endometriosis 
Scientific Title of Study   A, multicentre, prospective, open labeled phase IV study to evaluate safety and efficacy of Dienogest in patients suffering from endometriosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
DIE/PMS/PHASE IV/13/2020 Version: 2.0, Dated: 09 July, 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Varun Kumar 
Designation  Head Clinical Trials  
Affiliation  Qaaf Healthcare International 
Address  A-62, Basement, Suite No -B01, DDA Shed, Okhla Industrial Area, Phase -II New Delhi-110020, India

South
DELHI
110020
India 
Phone  9540430080  
Fax    
Email  varun@qaafhealth.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Kultaran Singh 
Designation  Director Corporate Affairs 
Affiliation  Jagsonpal Pharmaceuticals Limited 
Address  T-210 J, Shahpur Jat, New Delhi -110049, India.

New Delhi
DELHI
110049
India 
Phone  09810031631  
Fax    
Email  kultaran@jagsonpal.com  
 
Details of Contact Person
Public Query  
Name  Mr Kultaran Singh 
Designation  Director Corporate Affairs 
Affiliation  Jagsonpal Pharmaceuticals Limited 
Address  T-210 J, Shahpur Jat, New Delhi -110049, India.

New Delhi
DELHI
110049
India 
Phone  09810031631  
Fax    
Email  kultaran@jagsonpal.com  
 
Source of Monetary or Material Support  
Jagsonpal Pharmaceuticals Limited T-210J, Shahpur Jat, New Delhi, India 
 
Primary Sponsor  
Name  Jagsonpal Pharmaceuticals Limited 
Address  T-210J, Shahpur Jat, New Delhi, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pruthwiraj Sethi  AIIMS Bhubneshwar  AIIMS Sijua, Patrapada, Bhubaneshwar, Odisha, 751019 India
Khordha
ORISSA 		 9438884132

drpruthwiraj@gmail.com 
Dr Suchitra Narayan  JawaharLal Nehru Medical College and Attached Hospital   Department of Gynecology, Kala Bagh, Ajmer, Rajasthan-305001 India
Ajmer
RAJASTHAN 		 9351580306

narayan_jaiprakash@yahoo.co.in 
Dr Tamkin Khan  Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University  Department of Obstetrics and Gynecology, Civil Line Koil Aligarh Uttar Pradesh 202002
Aligarh
UTTAR PRADESH 		 9412485219

tamkinrabbani@gmail.com 
Dr Anjali Suneel Mundkur  Kasturba Medical College, MAHE-Manipal  Department of Reproductive Medicine and Surgery, Kasturba Medical College, Manipal Academy of Higher Education, MAHE-Manipal, Udupi, Karnataka, 576104 India
Udupi
KARNATAKA 		 9686448802

anjali.suneel@manipal.edu 
Dr Cimona Lyn Saldanha  Sher-i-Kashmir Institute of Medical Sciences (SKIMS)  Dept. of Obstetrics and Gynecology Sher-i-kashmir Institute of Medical Sciences (SKIMS) Soura, 190011 Srinagar, Jammu and Kashmir
Srinagar
JAMMU & KASHMIR 		 9419006658

clyns@rediffmail.com 
Dr Pragya Pandey  Shubham Sudbhawana Superspeciality Hospital  Department Of Gynecology, Room number 114, B31/80, 23B-Bhogabir Lanka Varanasi-221005 UP India.
Varanasi
UTTAR PRADESH 		 9696519115

pragyamadhukar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institutional Ethics Committee Jawahar Lal Nehru Medical college and attached Hospital, Kala Bagh, Ajmer, Rajasthan-305001 India  Approved 
Institutional Ethics Committee Sher-i-kashmir Institute Of Medical Sciences Soura Srinagar Jammu And Kashmir - 190011  Approved 
Institutional Ethics Committee, Aiims Bhubaneswar  Approved 
Institutional Ethics Committee, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University Civil Line Koil Aligarh Uttar Pradesh 202002  Approved 
Institutionl Ethics Committee MAHE Ethics Committee Manipal  Approved 
Shubham Sudbhawana Super Specialty Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N809||Endometriosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dienogest  2mg OD, Oral for 12 weeks(90 days) 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  1.Patients with a confirmed diagnosis of Endometriosis based on laparoscopy or
imaging
2.Patients who receive a prescription of DIENOGEST according to the
indication stated in the local approved SmPC.
3.Written informed consent signed by the patient or legally acceptable
representative(s) in line with applicable re.gulation of country.
4.Planned treatment in line with the Summary of Product Characteristics, i.e.
exclusion of all patients with contraindications. 
 
ExclusionCriteria 
Details  1.Exclusion of all patients with contraindications as per Investigators discretion 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Safety
The criteria for the assessment of safety and tolerability will be described in terms
of adverse events and change in laboratory tests.
1.Adverse events (based on severity grades, patterns, and causality).
2.Serious adverse events (SAE; in terms of severity)
3.Clinically significant derangement in lab results
4.Clinically significant changes in vital signs, demographics, gynaecologic
examination, breast examination, bleeding pattern. 		 After end of treatment ie., 12 weeks (90 days) 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy
Clinical response: Clinical responses will be evaluated on the basis of changes in
clinical sign/symptoms, lesion reduction and reduction in pain intensity in terms of
dysmenorrhea and low back pain in endometriosis and are categorized as “cure”
and “failure”.
 		 After end of treatment ie., 12 weeks (90 days) 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Phase 4 
Date of First Enrollment (India)   29/10/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This is a, multicentre, prospective, open labeled phase IV study to evaluate safety and efficacy of Dienogest 2mg daily for 12 weeks (90 days) in patients suffering from endometriosis that will be conducted across various sites in India. The primary safety variables include:
1.Adverse events (based on severity grades, patterns, and causality)
2. Serious adverse events (SAE; in terms of severity)
3. Clinically significant derangement in laboratory parameters
4. Clinically significant changes in vital signs, demographics, gynaecologic examination, breast examination, bleeding pattern (number of days, number of episodes, and duration of episodes with bleeding/spotting or spotting only)
Other safety variable are 
Tolerability: The assessment of tolerability will be performed by the investigator based on investigator assessment questionnaire. The responses will be graded as “excellent”, “good”, “fair”, and “not well tolerated”.
Efficacy
Primary variables
Clinical response: Clinical responses will be evaluated on the basis of changes in clinical sign/symptoms, lesion reduction and reduction in pain intensity in terms of dysmenorrhea and low back pain in endometriosis and are categorized as “cure” and “failure”. These are defined as follows:
1.Cure: Resolution of clinical signs and symptoms of original disease, not requiring further treatment
2. Failure: Persistence of clinical signs and symptoms or worsening in signs and symptoms that required alternative treatment or death. To categorize as clinical failure at least three weeks of therapy should have been administered
 
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