FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096305 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 22/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Effect of harmonal intrauterine devices on heavy periods and uterine blood flow. 
Scientific Title of Study   Effect of levonorgestrel releasing intrauterine system on heavy menstrual bleeding and uterine artery doppler indices A prospective quasi experimental 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  Dr Monisha S  
Designation  Assistant professor  
Affiliation  JR Medical College and Hospital 
Address  Department of Obstetrics and Gynecology JR Medical College and Hospital Kiledaiyalam Tindivanam

Viluppuram
TAMIL NADU
604302
India 
Phone  9791618813  
Fax    
Email  monishasnavinya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shriram N 
Designation  Assistant Professor  
Affiliation  JR Medical College and Hospital  
Address  Department of Radiodiagnosis JR Medical College and Hospital Kiledaiyalam Tindivanam

Viluppuram
TAMIL NADU
604302
India 
Phone  9894673006  
Fax    
Email  shriramn11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shriram N 
Designation  Assistant Professor  
Affiliation  JR Medical College and Hospital  
Address  Department of Radiodiagnosis JR Medical College and Hospital Kiledaiyalam Tindivanam

Viluppuram
TAMIL NADU
604302
India 
Phone  9894673006  
Fax    
Email  shriramn11@gmail.com  
 
Source of Monetary or Material Support  
JR Medical College and Hospital Kiledaiyalam Tindivanam  
 
Primary Sponsor  
Name  Dr Monisha S 
Address  JR Medical College and Hospital Kiledaiyalam Tindivanam  
Type of Sponsor  Other [SELF] 
 
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 Monisha S  JR Medical College and Hospital  Department of Obstetrics and Gynecology JR Medical College and Hospital Kiledaiyalam Tindivanam 604302
Viluppuram
TAMIL NADU 
9791618813

monishasnavinya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JR Medical College and Hospital Institutional Ethics Comittee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N921||Excessive and frequent menstruation with irregular cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levonorgestrel intrauterine system   52mg total dose releases 26microgram per day inserted for 6 months  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Clinical diagnosis of heavy menstrual bleeding
Uterine size less than 14 weeks
Multiparous women
Failed oral medications
Willing to give informed consent
 
 
ExclusionCriteria 
Details  Congenital or acquired uterine anomalies
Submucous fibroid distorting the uterine cavity
Uterine size more than 14 weeks
Acute pelvic inflammatory disease
Malignancy or suspected endometrial cancer  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pictorial blood assessment chart PBAC score and Hemoglobin   At insertion and 3 months and 6 months post insertion of levonorgestrel intrauterine system  
 
Secondary Outcome  
Outcome  TimePoints 
Endometrial thickness   At insertion and 3months and 6 months post insertion of levonorgestrel intrauterine system  
Resistance index and pulsatility index of arcuate and radial arteries  At insertion and 3 months and 6 months post insertion of levonorgestrel intrauterine system  
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   20/11/2025 
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 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  

This is a prospective quasi experimental pre post intervention study conducted in the

Department of Obstetrics and Gynaecology at J R Medical College and Hospital Tindivanam.

After obtaining approval from the Institutional Ethics Committee and written informed consent

from participants eligible women aged 30–45 years with heavy menstrual bleeding will

be recruited from the gynecology outpatient department. Baseline data including detailed

menstrual history PBAC scoring physical and pelvic examination and relevant investigations

 will be collected. A Pap smear and endometrial biopsy will be performed to

rule out malignancy. Transvaginal sonography will be carried out to assess endometrial

thickness and uterine artery Doppler indices the resistance index and pulsatility index

in the arcuate and radial arteries. Color Doppler ultrasound was used to pinpoint the arcuate artery

in the outer myometrial layer and radial arteries extending into the endometrium. A pulsed wave

Doppler, set at a 2 mm sampling size and an insonation angle under 30 degrees. The mean Pulsatility

Index and Resistance Index were automatically calculated from at least three consistent

waveforms. Following the baseline assessment all participants will undergo insertion of a

levonorgestrel releasing  intrauterine system 52 mg releasing 20 mcg per day using asterile no touch technique in the OPD. Participants will be advised to maintain a menstrual diary

to track PBAC scores throughout the study period. Follow-up visits will be conducted at 3

months and 6 months post insertion. At each follow up PBAC scores and hemoglobin levels

will be recorded and  repeat TVS with Doppler will be performed to reassess endometrial

thickness and uterine artery flow indices. Data will be analyzed to assess changes in primary

outcomes the PBAC score and hemoglobin levels and secondary outcomes (endometrial

thickness and Doppler indices  at 3 and 6 months compared to baseline.


 
Close