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CTRI Number  CTRI/2025/10/096374 [Registered on: 23/10/2025] Trial Registered Prospectively
Last Modified On: 22/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the efficacy of mifepristone as compared to oral progesterone in management of heavy menstrual bleeding 
Scientific Title of Study   Efficacy of mifepristone as compared to oral progestin therapy in management of acute abnormal uterine bleeding: a randomised pilot study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AIIMS A 4096  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditi Kumari 
Designation  Junior Resident ( Academic) 
Affiliation  AIIMS New Delhi 
Address  Department of Obstetrics and Gynaecology, Ansari Nagar,AIIMS New Delhi

South
DELHI
110029
India 
Phone  8084663618  
Fax    
Email  aditi02honey@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Vidushi Kulshrestha 
Designation  Prpfessor and Guide 
Affiliation  AIIMS New Delhi 
Address  Department of OBstetrics and Gynaecology, AIIMS New Delhi, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9891910880  
Fax    
Email  drvidushi.kul@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aditi Kumari 
Designation  Junior Resident ( Academic) 
Affiliation  AIIMS New Delhi 
Address  Department of OBstetrics and Gynaecology, AIIMS New Delhi, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  8084663625  
Fax    
Email  aditi02honey@gmail.com  
 
Source of Monetary or Material Support  
Department of Obstetrics and Gynaecology, AIIMS New Delhi, Ansari Nagar, New Delhi- 110029, India 
 
Primary Sponsor  
Name  Dr Aditi Kumari  
Address  Department of Obstetrics and Gynaecology, AIIMS New Delhi, Ansari Nagar, New Delhi- 110029 
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 Aditi Kumari  AIIMS New Delhi  Department of Obstetrics and Gynaecology, AIIMS New Delhi, Ansari Nagar, New Delhi- 110029
South
DELHI 
8084663625

aditi02honey@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N924||Excessive bleeding in the premenopausal period,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  medroxy progesterone acetate  Tab medroxy progesterone acetate 20 mg thrice daily ( total 60 mg in one day) for 5 days followed by 10 mg bd ( total 20 mg in one day) for 21 days in one cycle 
Intervention  mifepristone  Tab mifepristone 50 mg twice daily per oral for 5 days 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  REPRODCTIVE AGE FEMALES WILLING TO PARTICIPATE IN STUDY 
 
ExclusionCriteria 
Details  pregnant patients, local lesions in cervix and vagina, known case of genital tract malignancy, deranged lft, women requiring immediate surgical intervention or UAE 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Number of patients responding to each treatment in terms of decrease in blood loss within 5 days of starting treatment  Number of patients responding to each treatment in terms of decrease in blood loss within 5 days of starting treatment 
 
Secondary Outcome  
Outcome  TimePoints 
PBAC Score from initiation of treatment till cessation of bleeding  5 days 
Efficacy of mifepristone as compared to oral progestin therapy in different etiologies of acute AUB in terms of reduction in PBAC score  14 days 
Comparison of timr taken for cessation of blood loss in both groups  14 days 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   12/11/2025 
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="2"
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  

Topic Efficacy of mifepristone compared to oral progestin therapy in management of acute aub

This study is designed as a randomized controlled pilot trial to be conducted in the Department of Obstetrics and Gynaecology, AIIMS New Delhi. The participants will include non-pregnant women of reproductive age presenting with acute abnormal uterine bleeding . Eligible women will be  screened based on inclusion and exclusion criteria, and those consenting will be  randomized using a computerized table with concealed allocation. A total of 110 subjects will be recruited and will be divided equally into two groups.

Group 1 will  receive oral mifepristone 50 mg twice daily for five days or until cessation of bleeding  while Group 2 will receive oral medroxyprogesterone acetate 20 mg thrice daily for five days followed by 10 mg twice daily for 21 days. Tranexamic acid 500 mg  8 hourly will be administered additionally in either group if required. All participants shall receive oral iron supplementation.

The primary outcome will be  measured in terms of the number of women achieving cessation of bleeding within five days of initiating treatment. Secondary outcomes will include time taken for cessation of bleeding reduction in blood loss assessed by PBAC scores comparative efficacy of mifepristone versus progestins across different etiologies requirement of additional tranexamic acid, and patient satisfaction.

Participants will undergo baseline investigations and follow-up including clinical and laboratory evaluation. Response to treatment will be  assessed after two weeks either in person or telephonically with PBAC scoring used for quantification. All women will be  further evaluated to determine the underlying cause of AUB and will be  provided with definitive management along with treatment for iron deficiency or anemia where indicated.

 

 
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