Safety and Efficacy of Dienogest Tablets in Management of Pelvic Pain Associated with Endometriosis (abnormal tissue growth lying outside uterus)
- Conditions
- Endometriosis, unspecified,
- Registration Number
- CTRI/2022/04/041959
- Lead Sponsor
- Sun Pharma Laboratories Limited
- Brief Summary
This is a Phase IV, prospective, single arm, multicentre,open label study. The study will be initiated only after the receiptof regulatory and ethics committee (EC) approval. Patients will be explained about the entire scope of the researchstudy and all the procedures of the study, along with the risks and thebenefits to the patient, if they chose to participate in this study. Afterobtaining the written informed consent, subject will be screened by undergoingvarious assessments as mentioned in Schedule of Assessment (Appendix I). Afterconfirming the eligibility, if the subject fulfils all the eligibility criteriasubject will be enrolled by allotting the enrolment number. The enrolledsubject will consume the study medication, one tablet every day, continuouslyfor 12 weeks. This will be the treatment period. During the study, assessmentswill be performed as mentioned in Schedule of Assessment (Appendix I). Patientswill be provided with diary to record details about study drug administrationand adverse events. Patients will be required to bring completed diary at eachvisit.Patients discontinuing early from the study will be completing Visit 5assessments. Visit 5 will be considered as end of treatment visit & end ofstudy visit. The safety and efficacy will be assessed during the study period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 232
- 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)].
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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 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
Trial Locations
- Locations (16)
Apollo Institute of Medical Sciences and Research
🇮🇳Hyderabad, TELANGANA, India
B J Govt Medical College and Sassoon General Hospitals
🇮🇳Pune, MAHARASHTRA, India
B J Medical college and Civil hospital
🇮🇳Ahmadabad, GUJARAT, India
Dr. RML Institute of Medical Sciences
🇮🇳Lucknow, UTTAR PRADESH, India
GSVM Medical College
🇮🇳Nagar, UTTAR PRADESH, India
Hi-tech Multispeciality Hospital
🇮🇳Gandhinagar, GUJARAT, India
Institute of Medical Sciences and SUM Hospital
🇮🇳Khordha, ORISSA, India
Ishwar Institute of Health Care
🇮🇳Aurangabad, MAHARASHTRA, India
King George’s Medical University
🇮🇳Lucknow, UTTAR PRADESH, India
Life Line Diagnostics Centre Cum Nursing Home
🇮🇳Kolkata, WEST BENGAL, India
Scroll for more (6 remaining)Apollo Institute of Medical Sciences and Research🇮🇳Hyderabad, TELANGANA, IndiaDr Krishna Kumari MekaPrincipal investigator9849175200doc_krishnak@yahoo.co.in