| CTRI Number |
CTRI/2026/01/101119 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
treatment outcomes of dienogest versus elagolix in endometriosis |
|
Scientific Title of Study
|
Comparative Effectiveness of Dienogest and Elagolix in Endometriosis: A Prospective Observational Study at a Tertiary Care Centre in Northern India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrGhulam Nabi Bader |
| Designation |
Associate Proffesor |
| Affiliation |
Department of Pharmaceutical Sciences University of kashmir |
| Address |
Department of Pharmaceutical Sciences University of kashmir hazratbal Srinagar Jammu and Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006224042 |
| Fax |
|
| Email |
gbader2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syed Aatir Farooq |
| Designation |
PG Scholar |
| Affiliation |
Department of Pharmaceutical Sciences University of kashmir |
| Address |
Department of Pharmaceutical Sciences University of kashmir hazratbal Srinagar Jammu and Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
9149650374 |
| Fax |
|
| Email |
syedaatir06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGhulam Nabi Bader |
| Designation |
Associate Proffesor |
| Affiliation |
Department of Pharmaceutical Sciences University of kashmir |
| Address |
Department of Pharmaceutical Sciences University of kashmir hazratbal Srinagar Jammu and Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006224042 |
| Fax |
|
| Email |
gbader2007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
University of Kashmir |
| Address |
Hazrztbal Srinagar Jammu and Kashmir 190006 India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ghulam Nabi Bader |
SKIMS MEDICAL COLLEGE HOSPITAL |
Department of obstetrics and gynecology ,ward 8, and OPD Bemina srinagar 190018 jammu and kashmir
Srinagar
JAMMU & KASHMIR |
7006224042
gbader2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sher-i-Kashmir institute of Medical Sciences Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dienogest |
Dose 2 mg once a day orally
for three months |
| Intervention |
Elagolix |
dose 150 mg once a day orally
for three months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Female patients aged 18 to 45 years
Diagnosed with endometriosis clinical or USG based
VAS pelvic pain score equal or greater than 4 Willing to undergo 3 months of treatment and follow up
Provided written informed consent
|
|
| ExclusionCriteria |
| Details |
Hormonal therapy or surgery for endometriosis in past 3 months
Significant hepatic renal or bone disease
Pregnancy or lactation
Other pelvic pathologies mimicking endometriosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in pelvic pain score VAS |
Three months after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life |
three months after treatment |
Uterine Volume
Endometrioma Volume
Fluid Cyst volume |
three months after treatment |
| CA 125 levels |
Three months after Treatment |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
27/01/2026 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Endometriosis is a chronic, estrogen dependent condition affecting reproductive-aged women, often leading to pelvic pain infertility and reduced quality of life Dienogest and Elagolix are commonly prescribed hormonal therapies with distinct mechanisms, safety profiles and cost implications This Prospective observational Study aims to evaluate the effectiveness tolerability and cost-efficiency of Dienogest (2 mg once daily) versus Elagolix (150 mg once daily) over a three-month period in women with symptomatic endometriosis Outcomes will include reduction in pelvic pain (VAS) improvement in quality of life (WHOQOL-BREF), changes in serum CA-125 and, ultrasound-based lesion assessment Cost-effectiveness will be analyzed in relation to clinical benefit The study seeks to generate real-world evidence to guide affordable and effective treatment decisions in resource-limited settings |