| CTRI Number |
CTRI/2025/09/094233 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to determine the effects of oral medication ormeloxifene and Intrauterine device LNG-IUS (a small T shaped device that is placed inside the uterus) in women of age 18 to 45 years with uterine fibroids in reducing heavy menstrual bleeding, pain during menses and pain during menses |
|
Scientific Title of Study
|
Comparison of efficacy of ormeloxifene (centchroman) and levonorgestrel intrauterine system in treatment of uterine leiomyoma in women of reproductive age group: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Radhika Chandra |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Raebareli |
| Address |
Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Raebareli, Dalmau Road, Munshiganj, Raebareli, Uttar Pradesh, India
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
9380232578 |
| Fax |
|
| Email |
radhikachandra99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apala Priyadarshini |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Raebareli |
| Address |
Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Raebareli, Dalmau Road, Munshiganj, Raebareli, Uttar Pradesh, India
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
|
| Fax |
|
| Email |
apalapriyadarshini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Radhika Chandra |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Raebareli |
| Address |
Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Raebareli, Dalmau Road, Munshiganj, Raebareli, Uttar Pradesh, India
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
9380232578 |
| Fax |
|
| Email |
radhikachandra99@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Radhika Chandra |
| Address |
Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Raebareli, Dalmau Road, Munshiganj, Raebareli, Uttar Pradesh, India, pincode 229405 |
| Type of Sponsor |
Other [Self] |
|
|
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 Radhika Chandra |
All India Institute of Medical Sciences, Raebareli |
Department of Obstetrics and Gynecology
Rae Bareli
UTTAR PRADESH |
09380232578
radhikachandra99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bioethics Cell, AIIMS Raebareli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D25||Leiomyoma of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Levonorgestrel Intrauterine system |
a T shaped intrauterine device containing 52 mg of levonorgestrel releasing 20 mcg per day
locally, effective for 5 years. |
| Intervention |
Ormeloxifene |
Ormeloxifene, or centchroman, a selective estrogen receptor modulator(SERM), is a non
steroidal chemical with weak estrogenic and prominent anti-estrogenic activity and minimal side
effects used at a dose of 60mg twice a week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women presenting with complaint of heavy menstrual bleeding, with or without
dysmenorrhea.
Women detected to have uterine leiomyoma(AUB-L)- Upto 3 in number of size up to 5
cm each and FIGO stage 2-6, on transvaginal/transabdominal ultrasonography.
Women giving informed consent. |
|
| ExclusionCriteria |
| Details |
Known or suspected pregnancy.
Unexplained uterine bleeding.
Acute pelvic inflammatory disease (PID).
Uterus more than 12 weeks size.
Bleeding disorders or coagulopathies or receiving anticoagulants.
Contraindication to LNG-IUS or ormeloxifene. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Menstrual blood loss (MBL) as per Pictorial Blood Assessment Chart
(PBAC) |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in dysmenorrhea as indicated on Visual Analogue Scale(VAS) |
3 months |
Decrease in total volume of leiomyoma(s) on transvaginal/transabdominal
ultrasonography |
3 months |
| Adverse effects as reported by participant |
3 months |
|
|
Target Sample Size
|
Total Sample Size="284"
Sample Size from India="284"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="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 is an open label randomised control trial comparing the efficacy of levonorgestrel intrauterine system and oral ormeloxifene 60 mg biweekly in women of reproductive age group with uterine fibroid in a single centre in India. The primary outcome measure is reduction in menstrual blood loss. The secondary outcome measures will be reduction in dysmenorrhea and fibroid size. |