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CTRI Number  CTRI/2024/05/068177 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 20/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Usefullness of Levonorgestrel intrauterine system in the treatment of Heavy menstrual bleeding 
Scientific Title of Study   Safety, efficacy, and acceptability of Levonorgestrel intrauterine system in the management of Abnormal uterine bleeding 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Himangshu Malakar 
Designation  Assistant Professor 
Affiliation  AIIMS Guwahati 
Address  AIIMS Guwahati, Department of Obstetrics and Gynaecology, Room No. 65, Silbharal, Changsari, Kamrup

Kamrup
ASSAM
781101
India 
Phone  9854609022  
Fax    
Email  himangshumalakar@aiimsguwahati.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Himangshu Malakar 
Designation  Assistant Professor 
Affiliation  AIIMS Guwahati 
Address  AIIMS Guwahati, Department of Obstetrics and Gynaecology, Room No. 65, Silbharal, Changsari, Kamrup

Kamrup
ASSAM
781101
India 
Phone  9854609022  
Fax    
Email  himangshumalakar@aiimsguwahati.ac.in  
 
Details of Contact Person
Public Query  
Name  Himangshu Malakar 
Designation  Assistant Professor 
Affiliation  AIIMS Guwahati 
Address  AIIMS Guwahati, Department of Obstetrics and Gynaecology, Room No. 65, Silbharal, Changsari, Kamrup

Kamrup
ASSAM
781101
India 
Phone  9854609022  
Fax    
Email  himangshumalakar@aiimsguwahati.ac.in  
 
Source of Monetary or Material Support  
AIIMS Guwahati, Silbharal, Changsari, Kamrup, Assam, India. Pin: 781101 
 
Primary Sponsor  
Name  AIIMS Guwahati 
Address  AIIMS Guwahati, Silbharal, Changsari, Kamrup, Assam, India. Pin: 781101 
Type of Sponsor  Government medical college 
 
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 Himangshu Malakar  AIIMS Guwahati  Department of Obstetrics and Gynaecology,Room No. 65, Silbharal, Changsari
Kamrup
ASSAM 		 9854609022

himangshumalakar@aiimsguwahati.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, All India Institute of Medical Sciences, Guwahati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Women diagnosed with AUB

2. HMB due to benign conditions like idiopathic HMB, fibroid not distorting uterine cavity, adenomyosis, Iatrogenic causes, coagulopathies

 
 
ExclusionCriteria 
Details  1. Active genital tract infection
2. Severe anaemia
3. Pregnancy
4. Patients who are planning pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy of LNG IUS in decreasing menstrual blood loss by using PBAC chart  1, 3, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Haemoglobin levels  1, 3, 6 months 
Acceptibility of LNG IUS using Likert scale.  1, 3, 6 months 
 
Target Sample Size   Total Sample Size="87"
Sample Size from India="87" 
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)   24/10/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [himangshumalakar@aiimsguwahati.ac.in].

  6. For how long will this data be available start date provided 13-10-2025 and end date provided 13-10-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Abnormal uterine bleeding is quite common condition in women of reproductive age group and is a very frequent cause of hysterectomy. LNG IUS is a non surgical, minimally invasive long term treatment option for AUB. It is a desirable option to hysterectomy for AUB. The objectives of this study is to evaluate its safety, efficacy and acceptability in patients with AUB. Patients presenting with AUB to the OBGY OPD will be enrolled for the study after they give consent for the study and fulfill the inclusion and exclusion criteria. After proper evaluation LNG will be inserted and will be followed up at an interval of 1, 3 and 6 months to determine the safety, efficacy and acceptability of LNG IUS. 
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