| CTRI Number |
CTRI/2026/02/103054 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two medicines used in treating excessive bleeding and pain abdomen in women |
|
Scientific Title of Study
|
Comparison Of Efficacy Of Letrozole And Ormeloxifene In The Management of Abnormal Uterine Bleeding(AUB-A)- A Randomised Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
veluri lakshmi vennela reddy |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JIPMER |
| Address |
Department of obstetrics and gynecology, WCH building, JIPMER hospital
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9347458081 |
| Fax |
|
| Email |
velurivennela@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KUBERA N s |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Department of obstetrics and gynecology, jipmer hospital near wch building
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442550604 |
| Fax |
|
| Email |
ns.drkubera@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
veluri lakshmi vennela reddy |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JIPMER |
| Address |
department of obstetrics and gynecology, jipmer hospital near wch building
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9347458081 |
| Fax |
|
| Email |
velurivennela@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER, dhanavanthri nagar,jipmer campus road, gorimedu,puducherry,India- 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 veluri lakshmi vennela reddy |
WCH HOSPITAL,JIPMER |
Room no 5, gynecology OPD,Department of obstetrics and gynecology, WOMEN AND CHILDREN HOSPITAL, JIPMER INSTITUTE
Pondicherry
PONDICHERRY |
09347458081
velurivennela@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-INTERVENTIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N800||Endometriosis of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Letrozole |
Letrozole 2.5mg thrice weekly for 24 weeks |
| Comparator Agent |
Ormeloxifene |
Ormeloxifene 60mg twice weekly for 12 weeks followed by 60mg weekly for next 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
women aged more than 18 years who are diagnosed with adenomyosis based on MUSA criteria |
|
| ExclusionCriteria |
| Details |
Other asoociated pelvic pathology, contraindications to ormeloxifene/letrozole,women with severe anemia requiring transfusions |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy of letrozole with ormeloxifene in reducing the symptoms and improving hemoglobin among women with abnormal uterine bleeding due to adenomyosis |
3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| efficacy of letrozole with ormeloxifne in improving overall quality of life among women with abnormal uterine bleeding due to adenomyosis |
3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/02/2026 |
| 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 single center, open label randomized controlled trial comparing the efficacy of letrozole and ormeloxifene in women aged more than 18 years with abnormal uterine bleeding due to adenomyosis diagnosed using MUSA ultrasound criteria. A total of 128 participants will be randomized using block randomization with allocation concealment by the SNOSE technique into two groups: one receiving letrozole 2.5 mg orally thrice weekly for 24 weeks and the other receiving ormeloxifene 60 mg twice weekly for 12 weeks followed by once weekly for the next 12 weeks. Primary outcomes include reduction in menstrual blood loss assessed by PBAC score, improvement in dysmenorrhea using VAS score, and change in hemoglobin levels, while secondary outcomes include quality of life assessed by WHOQOLBREF, amenorrhea rates, uterine volume, ultrasound features of adenomyosis, and adverse effects. Participants will be assessed at baseline, 12 weeks, and 24 weeks, with informed consent obtained and ethical principles strictly adhered to throughout the study. |