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CTRI Number  CTRI/2025/11/096880 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Evidence Generation study]  
Study Design  Single Arm Study 
Public Title of Study   Real-world study to understand how well Evagolix tablet works and how safe it is for women with endometriosis-related pain 
Scientific Title of Study   Reducing endometriosis-related pain with ELagolix (T. Evagolix): Investigation of EFficacy and saFety 
Trial Acronym  RELIEF STUDY 
Secondary IDs if Any  
Secondary ID  Identifier 
CT-25-007 Version No.: 1.0 Dated 14 Jul 25  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dimple Shah 
Designation  Head Medical Affiars 
Affiliation  Zyfis Lifesciences Private Limited  
Address  Zyfis Lifesciences Pvt. Ltd., 511, Silver Radiance 2, Near Shakti Arcade, Science City Road, Sola, Ahmedabad, Gujarat

Ahmadabad
GUJARAT
380060
India 
Phone  918866662183  
Fax    
Email  dimple.shah@zyfis.in   
 
Details of Contact Person
Scientific Query  
Name  Dr Dimple Shah 
Designation  Head Medical Affiars 
Affiliation  Zyfis Lifesciences Private Limited  
Address  Zyfis Lifesciences Pvt. Ltd., 511, Silver Radiance 2, Near Shakti Arcade, Science City Road, Sola, Ahmedabad, Gujarat

Ahmadabad
GUJARAT
380060
India 
Phone  918866662183  
Fax    
Email  dimple.shah@zyfis.in   
 
Details of Contact Person
Public Query  
Name  Kalpana Sharma 
Designation  Project Manager 
Affiliation  Zyfis Lifesciences Private Limited  
Address  Zyfis Lifesciences Pvt. Ltd., 511, Silver Radiance 2, Near Shakti Arcade, Science City Road, Sola, Ahmedabad, Gujarat

Ahmadabad
GUJARAT
380060
India 
Phone  9979724293  
Fax    
Email  kalpana.sharma@zyfis.in  
 
Source of Monetary or Material Support  
Corona Remedies Ltd. 
 
Primary Sponsor  
Name  Corona Remedies Ltd. 
Address  Corona House, Block C, Mondeal Business Park, S. G. Highway, Apex St, near Gurudwara, Thaltej, Ahmedabad, Gujarat 380059, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S Krishnakumar  JK Women Hospital  Ground floor, OPD 2, Medical department Maitri Raghukul, Shahid Bhagat Singh Rd, Near PP Chambers, Above BOI, Dombivali- 421201
Mumbai
MAHARASHTRA 		 9820067318

kk.jkwh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vision Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N809||Endometriosis, unspecified, (2) ICD-10 Condition: R102||Pelvic and perineal pain, (3) ICD-10 Condition: N941||Dyspareunia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Tablet Evagolix 150 mg for dysmenorrhea and non-menstrual pelvic pain Or Tablet Evagolix 200 mg for dyspareunia   orally once a day for 84 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  Patients will be included if they meet the following criteria:
1. Female subjects aged between 18 and 49 years (both ages inclusive).
2. Non-pregnant, non-lactating female patients.
3. Patient who has given consent for the study
4. Patient who has been diagnosed to suffer from
• Dysmenorrhea due to endometriosis
• Non-menstrual pelvic pain due to endometriosis
• Dyspareunia due to endometriosis
5. Patients willing to follow-up at scheduled visit as per protocol at same centre
6. Female who agrees to use required birth control methods during the entire length of participation in the study.
7. Female must have at least two regular menstrual cycles with an interval of 24-38 days within the Screening visit, prior to Day 1. 
 
ExclusionCriteria 
Details  Patients will be excluded if they have any of the following:
1. Patients with known hypersensitivity or severe allergic reactions to study drug or any of the excipients
2. Using other drugs for endometriosis treatment
3. Pregnant and lactating women
4. Patient with known osteoporosis
5. Patient with severe hepatic impairment
6. Patient with concomitant use of cyclosporine or gemfibrozil.
7. Patient is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of screening visit. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in Dysmenorrhea severity using Numeric Rating Scale (NRS)
Change in non-menstrual pelvic pain using Numeric Rating Scale (NRS)
Change in Dyspareunia using Numeric Rating Scale (NRS)
 		 Baseline visit Day 0, Week 4 and Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Use of rescue analgesics
Improvement in Health-related Quality of Life (HrQoL)
Incidence of adverse event
 		 Baseline Day 0, Week 4 and Week 12 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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   N/A 
Date of First Enrollment (India)   21/11/2025 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a post-approval, prospective, single-arm, open-label study evaluating the efficacy and safety of T. Evagolix (Elagolix) in women with endometriosis-related pain. The study enrolls 1,000 women aged 18–49 years with active endometriosis. Patients receive Evagolix 150 mg once daily for dysmenorrhea and non-menstrual pelvic pain, or 200 mg twice daily for dyspareunia. The primary endpoints are changes in dysmenorrhea, non-menstrual pelvic pain, and dyspareunia measured using the Numeric Rating Scale (NRS). Secondary endpoints include rescue analgesic use, improvement in health-related quality of life (HrQoL), and incidence of adverse events. The study duration is 12 weeks, with assessments at baseline, 4 weeks, and 12 weeks. Inclusion criteria include non-pregnant, non-lactating women with regular menstrual cycles and willingness to follow up. Exclusion criteria include hypersensitivity to the drug, osteoporosis, severe hepatic impairment, and use of other endometriosis treatments. Safety monitoring includes tracking all adverse events and serious adverse events. Data will be analyzed using descriptive statistics, ANOVA, and Fisher’s Exact Test with significance set at p < 0.05. 
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