| CTRI Number |
CTRI/2022/04/041870 [Registered on: 13/04/2022] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
post-approval Phase IV (Post-Market Clinical Follow-Up study) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess how safe and effective Visanne (Dienogest) is in managing pelvic pain caused due to endometriosis |
|
Scientific Title of Study
|
Phase IV study to assess the safety and effectiveness of
Dienogest (Visanne®) amongst Indian women with
Endometriosis, in real-world clinical practice: the VISAGE
Study |
| Trial Acronym |
VISAGE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 19837, V.4.0, Dated 08.03.2022 |
Protocol Number |
| NCT04808843 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Upal Vyas |
| Designation |
Therapeutic Area Head - Women Healthcare |
| Affiliation |
Bayer Pharmaceuticals |
| Address |
Bayer Pharmaceuticals, Bayer House, Central Avenue, Hiranandani Estate, Thane West
Thane
MAHARASHTRA
400607
India |
| Phone |
|
| Fax |
|
| Email |
upal.vyas@bayer.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Upal Vyas |
| Designation |
Therapeutic Area Head - Women Healthcare |
| Affiliation |
Bayer Pharmaceuticals |
| Address |
Bayer Pharmaceuticals, Bayer House, Central Avenue, Hiranandani Estate, Thane West
Thane
MAHARASHTRA
400607
India |
| Phone |
|
| Fax |
|
| Email |
upal.vyas@bayer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Upal Vyas |
| Designation |
Therapeutic Area Head - Women Healthcare |
| Affiliation |
Bayer Pharmaceuticals |
| Address |
Bayer Pharmaceuticals, Bayer House, Central Avenue, Hiranandani Estate, Thane West
Thane
MAHARASHTRA
400607
India |
| Phone |
|
| Fax |
|
| Email |
upal.vyas@bayer.com |
|
|
Source of Monetary or Material Support
|
| Bayer Pharmaceuticals Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Bayer Pharmaceuticals Pvt Ltd |
| Address |
Bayer House, Central Avenue, Hiranandani Estate, Thane West, Maharashtra- 400607 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vidushi Kulshreshtha |
All India Institute of Medical Sciences |
Department of Gynaecology and Obstetrics, Teaching Block, 3rd floor, Room- 3082-A, All India Institute of Medical Sciences, Ansari Nagar, New Delhi- 110029, India
New Delhi
DELHI |
9891910880
drvidushi.kul@gmail.com |
| Dr Chirag Amin |
Amins Hospital for Women |
17 Manipushp Society Opp Sarthi 2 Behind Goyal Intercity Theltej Ahmedabad 380054
Ahmadabad
GUJARAT |
9825067563
meenachirag@yahoo.co.in |
| Dr Bhaskar Pal |
Apollo Gleneagles Hospital |
Kolkata 58-Canal Circular Road, Kolkata -700 054
Kolkata
WEST BENGAL |
9831298236
palbas@hotmail.com |
| Dr Suryanarayan Mohanty |
Apollo Hospitals |
Plot Number 251 Sainik School Road Unit 15
Khordha
ORISSA |
8093060027
drsnmohanty@yahoo.com |
| Dr Pranab Kumar Biswas |
Calcutta National Medical College |
Professor in department of gynecology and obstetrics 32 Gorachand Road, Kolkata-14, West Bengal
Kolkata
WEST BENGAL |
9830134456
drpranabkrbiswas@gmail.com |
| Dr Gayathri Kamath |
Fortis Hospital |
senior consultant obstetrics and gynecology fortis hospital 154/9, Bannerghatta Road, Bangalore- 560076.
Bangalore
KARNATAKA |
9844172375
gayathri.kamath@fortishealthcare.com |
| Dr Jheelam Mukhopadhyay |
Healthworld Hospitals |
Department of Obstetrics and Gynecology Healthworld Hospitals C-49 Commercial area opp ESIC sub-regional office city centre Durgapur 713216
Barddhaman
WEST BENGAL |
9733307050
dr.jheelam@gmail.com |
| Dr Sangeeta Rai |
Institute of Medical Sciences, Banaras Hindu University |
Banaras Hindu University Institute of Medical Sciences Varanasi 221005
Varanasi
UTTAR PRADESH |
9621591247
drsangeeta1977@yahoo.co.in |
| Dr Manju Khemani |
Max Smart Super Speciality Hospital |
Saket Mandir Marg Press Enclave Road
New Delhi
DELHI |
9810611598
dr.manjukhemani@gmail.com |
| Dr Alka Kriplani |
Paras Hospital |
Director and head department of gynecology obstetrics and ART Paras Hospital Gurgaon Ex-professor and Head Department of Obstetrics and gynecology
Phase-1, C-1, Sushant Lok Road, Sector-43, Gurugram, Haryana- 122002
Gurgaon
HARYANA |
9810828717
kriplanialka16@gmail.com |
| Dr Ramani Devi |
Ramakrishna Medical Centre LLP |
19,20,21 Vivekananda Nagar, Woraiyur, Trichy- 620003
Tiruchirappalli
TAMIL NADU |
9443155282
ramanidevidr@yahoo.co.in |
| Dr Priti Vyas |
Sangita Maternity Surgical & Diagnostic Centre |
11 Gangavihar Residency 174 SV Road Behind Centre Square
Mumbai (Suburban)
MAHARASHTRA |
9869428728
drpritivyas@gmail.com |
| Dr Hephzibah Kirubamani |
Saveetha Medical College and Hospital |
Department of Obstetrics & Gynecology, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai- 602105
Chennai
TAMIL NADU |
9841043753
hepsi1002@yahoo.co.in |
| Dr Niranjan Mayadeo |
Seth GS Medical College and KEM Hospital |
Seth GS Medical College and KEM Hospital, Dr. E. B. Road, Parel, Mumbai – 400012
Mumbai
MAHARASHTRA |
8369884832
drmayadeo@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Adroit Ethics Committee |
Approved |
| Banaras Hindu University Ethics Committee |
Submittted/Under Review |
| Ethics Committee, Calcutta National Medical College (EC-CNMC) |
Approved |
| Fortis Hospital Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee - AIIMS |
Approved |
| Institutional Ethics Committee - Clinical Studies |
Approved |
| Institutional Ethics Committee - Clinical Trials |
Approved |
| Institutional Ethics Committee - Seth GS Medical College and KEM Hospital |
Submittted/Under Review |
| Institutional Ethics Committee-Paras Hospital |
Approved |
| Max Healthcare Ethics Committee |
Approved |
| Plasmaart Resto Ethical Committee |
Approved |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
| Shrey Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N809||Endometriosis, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Female patients in India at least 18 years of age
Clinical or surgical diagnosis of endometriosis: Clinical diagnosis by suggestive symptoms
and positive finding in imaging study (Chocolate cyst)
Patients diagnosed with endometriosis associated pelvic pain who have not been previously
treated with Dienogest
Decision to initiate treatment with Dienogest was made as per investigator’s routine
treatment practice
Signed informed consent |
|
| ExclusionCriteria |
| Details |
Participation in an investigational program with interventions outside of routine clinical
practice
Contra-indications according to the local summary of product characteristics (SPC) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective in this study is:
to assess the incidence of adverse events, in Indian Endometriosis patients on Dienogest therapy. |
0 months, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in endometriosis associated pelvic pain from baseline at six months, measured by 0-10
EAPP NRS. |
0 months, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
15/04/2022 |
| 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="2"
Months="6"
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
|
Endometriosis is a chronic, progressive, estrogen-dependent disease of unknown aetiology, with a prevalence rate of up to 10% in women in reproductive age-group. Since there is no known cure for endometriosis, management is aimed at reducing pain, minimizing disease progression and preserving fertility. Dienogest is a progestin with both local and central effects in reducing endometriosis associated pelvic pain, with a good safety profile. Based on the information from the clinical developmental program for Dienogest the Indian Health Authority (DCGI) has approved Dienogest for the management of pelvic pain associated with endometriosis and requested to carry out a phase IV post-approval study. The proposed regulatory postapproval Phase IV study is planned to assess the safety and effectiveness of Dienogest in patients in India with endometriosis associated pelvic pain, in real world clinical practice. |