CTRI/2022/04/041959 [Registered on: 20/04/2022] Trial Registered Prospectively
Last Modified On:
19/09/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
Safety and Efficacy of Dienogest Tablets in Management of Pelvic Pain Associated with Endometriosis (abnormal tissue growth lying outside uterus)
Scientific Title of Study
A Prospective, Multi-Center, Single Arm, Phase IV Study to Assess the Safety and Efficacy of Dienogest Tablets in Management of Pelvic Pain Associated with Endometriosis
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
ICR/19/007 Version No. 1.0; Dated 13/JAN/2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Lalit Lakhwani
Designation
AVP and Head-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited,
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai-400063, Maharashtra, India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
lalit.lakhwani@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Sapan Kumar Behera
Designation
MBBS, MD, DM
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited,
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai-400063, Maharashtra, India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
sapan.behera@sunpharma.com
Details of Contact Person Public Query
Name
Rajesh Gaikwad
Designation
Deputy General Manager – India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited,
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai-400063, Maharashtra, India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
rajesh.gaikwad@sunpharma.com
Source of Monetary or Material Support
Sun Pharma Laboratories Limited
Sun House, 201 B/1, Western Express Highway,
Goregaon ( E),Mumbai 400 063
Primary Sponsor
Name
Sun Pharma Laboratories Limited
Address
Sun House, 201 B/1, Western Express Highway,
Goregaon ( E),Mumbai 400 063
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Not Applicable
Not Applicable
Countries of Recruitment
India
Sites of Study
No of Sites = 16
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Krishna Kumari Meka
Apollo Institute of Medical Sciences and Research
Department of OBGYN, Room No. 2, Apollo Institute of Medical Sciences and Research, Apollo Hospitals, Jubillee Hills, Hyderabad 500096, Telangana, India Hyderabad TELANGANA
9849175200
doc_krishnak@yahoo.co.in
Dr Ambadkar Arun Narayan
B J Govt Medical College and Sassoon General Hospitals
3rd Floor, Department of Obst. and Gynaec,
B J Govt Medical College and Sassoon General Hospitals, Near Pune Railway Station, Pune- 411 001, Maharashtra, India
Pune MAHARASHTRA
9011053157
arun1728493@gmail.com
Dr Shital Natwarlal Kapadia
B J Medical college and Civil hospital
Department of Obstetrics and Gynecology, B.J. Medical college and Civil hospital, Asarwa, Ahmedabad 380016 Gujarat India Ahmadabad GUJARAT
9924643700
sheetalobgy@gmail.com
DrDevyani Misra
Dr. RML Institute of Medical Sciences
Room No 10, Ground Floor, Department of Gynaecology, A Unit of Child and Mother Referral, Dr. RML Institute of Medical Sciences, Vibhuti khand, Gomti Nagar, Lucknow 226010 Lucknow UTTAR PRADESH
9838855119
dr.devyanimisra@gmail.com
Dr Neena Gupta
GSVM Medical College
Room No.2, Ground Floor, Department of Gynecology, GSVM Medical College, Swaroop Nagar Kanpur-208002 Uttar Pradesh, India. Kanpur Nagar UTTAR PRADESH
9415131422
drneenagupta.research@gmail.com
Dr Viral T Luhar
Hi-tech Multispeciality Hospital
Room No. 06, Sector 3-D, Plot No. 1180, Gh Road, Near Gh-11/2 Bus Stand, Gandhinagar, Gujarat- 382003, India Gandhinagar GUJARAT
9824065533
hitechhospital.cr@gmail.com
Dr Tapasi Pati
Institute of Medical Sciences and SUM Hospital
Department of Obstetrics and Gynaecology, Institute of Medical Sciences and SUM Hospital, K 8, Kalinga Nagar, Ghatikia, Khandagiri, Bhubaneswar, Odisha 751003 Khordha ORISSA
933725168
tapasipati@soauniversity.ac.in
Dr Mhankale Ashok Bajirao
Ishwar Institute of Health Care
Ishwar Institute of Health Care, Ishawar Heights, 1st Floor Room no 107, Plot No 7, Gut No. 6/1, Beside Punjabi Bhavan, Padegaon, Aurangabad-431002, Maharashtra, India.
Aurangabad MAHARASHTRA
9822314268
ishwarhealthcare@gmail.com
Dr Sujata Deo
King George’s Medical University
Department of Obstetrics and Gynaecology (Queen Marry) Room No. 06, Ground Floor, Faculty block, King George’s Medical University Chowk Lucknow-226003, UP, India Lucknow UTTAR PRADESH
9415152570
drsujata.2008@rediffmail.com
Dr Mousumi Dutta
Life Line Diagnostics Centre Cum Nursing Home
Life Line Diagnostics Centre Cum Nursing Home Clinical Research Room, Room No-201 4A Wood Street, Kolkata – 700016, WB, India. Kolkata WEST BENGAL
9830424381
drmdms@gmail.com
Dr Tejasvini Adhav
Lifepoint Multispeciality Hospital
Lifepoint Multispeciality Hospital, 3rd Floor, Clinical Research Department, 145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune 411057, Maharashtra India Pune MAHARASHTRA
8805785212
adhav.tejasvini121@gmail.com
Dr Sidid Santosh Vasantrao
Noble Hospitals Pvt. Ltd
Gynac OPD No. 21, Noble Hospitals Pvt. Ltd.,Pune-153, Magarpatta City Road, Hadapsar, Pune- 411013, Maharashtra, India Pune MAHARASHTRA
9527042728
svspune1@gmail.com
Dr Shalini Srivastava
Om Surgical Center & Maternity Home
Room No. 203, Department of Obs & Gyn at ground floor, Om Research Center, Om Surgical Center & Maternity Home, SA 17/3, P-4, Sri Krishna Nagar, Ghazipur Road, Paharia, Varanasi, Uttar Pradesh- 221007, India Varanasi UTTAR PRADESH
1) Patient is willing to provide written informed consent
2) Female patient aged greater or equal to 18 and less than or equal to 45 years at the time of signing of the informed consent
3) Patient of endometriosis with pelvic pain documented by USG or laparoscopy
4) Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective non hormonal methods of contraception to prevent pregnancy from study entry till the last dose of the study medication [Note Woman with childbearing potential are defined as those who are not surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation)]
ExclusionCriteria
Details
1. Patient with chronic pelvic pain that is not attributed to Endometriosis
2. Patient with clinically established need for primary surgical treatment of endometriosis
3. Patient with known or suspected pregnancy
4. Lactating women
5. Patient planning to conceive during the study period
6. Patient with functional ovarian cysts
7. Patient with uncontrolled hypertension (systolic blood pressure greater than or equal to 160 mmHg OR diastolic blood pressure greater than or equal to 100 mmHg)
8. Patient with active venous thromboembolic disorder
9. Patient with current or history of arterial or cardiovascular disease such as coronary artery disease, congestive heart failure, arrhythmias, stroke or congenital heart disease.
10. Patient with HbA1c greater than 9.0%
11. Patient with severe renal impairment (eGFR less than 30 ml/min/1.73 m2)
12. Patient with vascular involvement as a consequence of Diabetes Mellitus
13. Patient with presence of severe hepatic disease (Chronic: Child Pugh C; Acute: Fatty liver grade greater than1 and INR greater than 1.5)
14. Patient with history of severe hepatic disease with abnormal liver function
15. Patient with presence or history of liver tumors (benign or malignant)
16. Patient with any known OR suspected malignancies
17. Patient with undiagnosed abnormal vaginal bleeding
18. Patient suffering from ophthalmic vascular disease
19. Patient with current OR history of migraine with focal aura
20. Patient who is a known case of osteoporosis or who in opinion of investigator, is at increased risk of osteoporosis
21. Patient is a smoker and expresses inability to cease smoking during the study.
22. Patient with history of OR suffering from depression
23. Patient with history of HIV, Hepatitis B and HCV
24. Patient who is on steroids (eg danazol) or planning to take during the study.
25. Patient having intolerance, hypersensitivity or any contraindication to any of the study drug or other components.
26. Patient with current or recent substance abuse, including alcohol as per Diagnostic and Statistical Manual fifth edition criteria
27. Patient with history of participation in another clinical trial in the past 30 days of screening or planning to participate during the study
28. Patient who has a clinically significant disorder that, in the opinion of the investigator, would result in the participant’s inability to understand and comply with the requirements of the study.
29. Investigators, study personnel, sponsor representatives and their first degree relatives.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Proportion of participants with treatment emergent adverse events as a measure of safety and tolerability in patients who have consumed ATLEAST one dose of study medication
Timeframe of 12 weeks
Secondary Outcome
Outcome
TimePoints
Proportion of participants with amenorrhea, spotting, infrequent bleeding, frequent bleeding, irregular bleeding, prolonged bleeding upon treatment who have consumed ATLEAST one dose of study medication
Timeframe of 12 weeks
Percentage of treatment responders [response is defined as a reduction in pain intensity from baseline of at least 30% in the Visual Analogue Scale (VAS) for EAPP]
Timeframe of 12 weeks
Absolute change in mean Endometriosis Associated Pelvic Pain (EAPP) measured by visual analogue scale (VAS) assessed from baseline to end of study
Time Frame of 4, 8 and 12 weeks
The change from baseline in the size of the endometriomas, as determined by pelvic ultrasound imaging
Timeframe of 12 weeks
Target Sample Size
Total Sample Size="232" Sample Size from India="232" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Phase IV, prospective, single arm, multicentre,
open label study. The study will be initiated only after the receipt
of regulatory and ethics committee (EC) approval. Patients will be explained about the entire scope of the research
study and all the procedures of the study, along with the risks and the
benefits to the patient, if they chose to participate in this study. After
obtaining the written informed consent, subject will be screened by undergoing
various assessments as mentioned in Schedule of Assessment (Appendix I). After
confirming the eligibility, if the subject fulfils all the eligibility criteria
subject will be enrolled by allotting the enrolment number. The enrolled
subject will consume the study medication, one tablet every day, continuously
for 12 weeks. This will be the treatment period. During the study, assessments
will be performed as mentioned in Schedule of Assessment (Appendix I). Patients
will be provided with diary to record details about study drug administration
and adverse events. Patients will be required to bring completed diary at each
visit.
Patients discontinuing early from the study will be completing Visit 5
assessments. Visit 5 will be considered as end of treatment visit & end of
study visit. The safety and efficacy will be assessed during the study period.