| 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
|
|
|
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
|
|
|
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.
|