| CTRI Number |
CTRI/2026/01/101789 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized Open-Label Trial Comparing GnRH Antagonist Monotherapy versus Add-Back Therapy(GnRH Antagonist with estrogen+progesterone)in Women with Uterine Fibroids and Abnormal Uterine Bleeding: Evaluation of Clinical and Bone Health Outcomes |
|
Scientific Title of Study
|
GNRH Antagonist monotherapy vs Add-back therapy in Abnormal Uterine Bleeding with Leiomyoma(AUB-L)- An open label randomized control trial assessing clinical and skeletal outcomes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Rai |
| Designation |
Additional Professor and HOD in dept of obstetrics and gynaecology |
| Affiliation |
AIIMS DEOGHAR |
| Address |
Department of Obstetrics and Gynaecology,
AIIMS Deoghar,
Devipur,Deoghar
Jharkhand
Deoghar
JHARKHAND
814152
India |
| Phone |
7534053157 |
| Fax |
|
| Email |
drpriyanka242@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Shukla |
| Designation |
Junior resident PG1 in dept of obstetrics and gynaecology |
| Affiliation |
AIIMS DEOGHAR |
| Address |
Department of Obstetrics and Gynaecology,
AIIMS Deoghar,
Devipur,Deoghar
Jharkhand
Deoghar
JHARKHAND
814152
India |
| Phone |
8967421676 |
| Fax |
|
| Email |
shalinishukla839@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalini Shukla |
| Designation |
Junior resident PG1 in dept of obstetrics and gynaecology |
| Affiliation |
AIIMS DEOGHAR |
| Address |
Department of Obstetrics and Gynaecology
AIIMS Deoghar,
Devipur,Deoghar
Jharkhand
Deoghar
JHARKHAND
814152
India |
| Phone |
8967421676 |
| Fax |
|
| Email |
shalinishukla839@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS DEOGHAR, DEVIPUR, JHARKHAND |
|
|
Primary Sponsor
|
| Name |
Dr Shalini Shukla |
| Address |
Department of obstetrics and gynaecology,
AIIMS Deoghar,Jharkhand-814152 |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 SHALINI SHUKLA |
AIIMS DEOGHAR |
Department of Obstetrics and Gynaecology,3rd floor,Block D AIIMS DEOGHAR,DEVIPUR,
JHARKHAND,INDIA
Deoghar
JHARKHAND |
8967421676
shalinishukla839@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS-DEO/RC-IEC-SUBCOMMITTEE/2025/107 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Estrogen(1mg) and progesterone(0.5mg) |
Estrogen(1mg) + Progesterone(0.5mg) per orally |
| Intervention |
GNRH Antagonist (150mg OD) per orally |
Treatment of AUB-L |
| Intervention |
GNRH Antagonist(150mg) + Estrogen(1mg) and Progesterone(0.5mg) per orally |
Treatment of AUB-L |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All reproductive age women 18-50 years with symptomatic abnormal uterine bleed associated with leiomyoma |
|
| ExclusionCriteria |
| Details |
1-Known case of osteoporosis
2-Contraindications to hormonal therapy
3-Previous surgical treatment of fibroids
4-Pregnancy,lactation or plans for conception
5-Known case of depression or mood disorders
6-Patients with hepatic impairment |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare efficacy of GNRH antagonist monotherapy vs add back therapy in reducing heavy menstrual flow associated with AUB-L, baseline values and at 3 and 6 months.
2.To evaluate change in BMD due to GNRH antagonist alone vs add back therapy at baseline and at 6 months. |
1.To compare efficacy of GNRH antagonist monotherapy vs add back therapy in reducing heavy menstrual flow assosciated with AUB-L at baseline and at 3 and 6 months.
2.To evaluate change in BMD due to GNRH antagonist alone vs add back therapy at baseline and at 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare side common side effects across across the 2 study arms. |
Lipid profiles & LFT 6 weekly. |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
03/02/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a randomized controlled trial designed to compare the efficacy of oral GnRH antagonist (elagolix) monotherapy versus elagolix with add-back therapy (estradiol and norethindrone acetate) in women aged 18–50 years with abnormal uterine bleeding due to leiomyoma (AUB-L). Uterine fibroids are a common cause of heavy menstrual bleeding and significantly impair quality of life, especially in low-resource settings where surgical management is often overused.
Eligible participants with ultrasound-confirmed fibroids and normal baseline bone mineral density will be randomized into two treatment arms and followed for six months. The primary outcomes include reduction in menstrual blood loss, improvement in hemoglobin levels, and changes in bone mineral density measured by DEXA scan. Secondary outcomes include assessment of side effects, pain scores, quality of life, and changes in fibroid size.
The study aims to generate region-specific evidence on the effectiveness of GnRH antagonist therapy with and without add-back treatment, highlighting a safe, non-surgical, fertility-preserving option for managing AUB-L while minimizing bone loss and improving overall quality of life. |