| CTRI Number |
CTRI/2026/04/107716 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
21/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing effects of two long acting methods, the implant (Implanon) and the three monthly injection (DMPA) - on menstrual bleeding patterns and uterine artery blood flow in women seeking contraceptives for family planning |
|
Scientific Title of Study
|
Study of effect of etonogestrel subdermal implant vs depot medroxyprogesterone acetate injection on menstrual bleeding patterns and uterine artery doppler changes |
| 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 ISHIKA CHITKARA |
| Designation |
Primary DNB Resident |
| Affiliation |
Dr Baba Saheb Ambedkar Medical college & Hospital, Rohini sector 6,, DELHI |
| Address |
Room no 206, Third floor, Dr. Baba Saheb Ambedkar
residential complex, Rohini, Sector 6,
New Delhi - 110085
North West
DELHI
110085
India |
| Phone |
8826010825 |
| Fax |
|
| Email |
chitkaraishika1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RASHMI KHATRI |
| Designation |
Senior specialist and Professor |
| Affiliation |
Dr. Baba Saheb Ambedkar medical college & Hospital, Rohini, Sector 6, New Delhi - 110085 |
| Address |
Room no 1211,OPD first floor, Dept of Obstetrics and gynecology, Dr. Baba Saheb Ambedkar
medical college & Hospital, Rohini, Sector 6,
New Delhi - 110085
North West
DELHI
110085
India |
| Phone |
8130940185 |
| Fax |
|
| Email |
drrashmikhatri20144@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RASHMI KHATRI |
| Designation |
Senior specialist and Professor |
| Affiliation |
Dr. Baba Saheb Ambedkar medical college & Hospital, Rohini, Sector 6, New Delhi - 110085 |
| Address |
Room no 1211,OPD first floor, Dept of Obstetrics and gynecology, Dr. Baba Saheb Ambedkar
medical college & Hospital, Rohini, Sector 6,
New Delhi - 110085
North West
DELHI
110085
India |
| Phone |
8130940185 |
| Fax |
|
| Email |
drrashmikhatri20144@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Baba Saheb Ambedkar
Hospital & medical
college, Rohini, Sector 6,
New Delhi - 110085 |
|
|
Primary Sponsor
|
| Name |
Dr Baba Saheb Ambedkar medical college Hospital Rohini Sector New Delhi |
| Address |
Dept of Obstetrics and gynecology, Dr. Baba Saheb Ambedkar
medical college & Hospital, Rohini, Sector 6,
New Delhi - 110085 |
| Type of Sponsor |
Government medical college |
|
|
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 ISHIKA CHITKARA |
Dr. Baba Saheb Ambedkar medical college & Hospital, Rohini, Sector 6, New Delhi - 110085 |
Labour room, First floor, Dept of obstetrics and gynecology Dr. Baba Saheb Ambedkar
Hospital & medical college,
Rohini, Sector 6, New Delhi -
110085
North West
DELHI |
8826010825
chitkaraishika1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of Dr. Baba Saheb ambedkar hospital and medical college, new delhi, 110085 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Depot medroxyprogesterone acetate injection ( DMPA) |
Intramuscular injection of 150mg medroxyprogesterone acetate administered once every 3 months
|
| Intervention |
Etonogestrel subdermal implant ( implanon) |
Single rod subdermal implant containing 68mg etonogestrel, inserted in non dominant upper arm under local anaesthesia; single insertion effective upto 3 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Young women aged 20-40 years old who desired interval Contraception and having no contraindication
for ENG implant or DMPA
2. No hormonal treatment for at least three months before insertion.
3. Patients who do not want to conceive for at least 1 year |
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Past or current history of Breast cancer
3., Liver disease
4. Any Contraindication to progestin administration
5. Nulliparity
6.Pts with AUB ( Structural causes: PALM- Polyp, Adenomyosis, Leiomyoma (fibroid), Malignancy and
hyperplasia and Nonstructural causes : COEIN :Coagulopathy, Ovulatory dysfunction, Endometrial,
Iatrogenic, Not yet classified (or not otherwise classified)
7. Nulliparity |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To study changes in menstrual bleeding patterns in etonogestrel ENG implant vs
DMPA
2) To study changes in uterine artery doppler in ENG implant vs DMPA
|
Pre insertion, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study the association of abnormal menstrual bleeding patterns with uterine artery
doppler
2) To study other side effects & reasons of discontinuation in patients with
ENG implant vs DMPA |
Pre insertion, 3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
15/04/2026 |
| 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 prospective randomized controlled study aims to compare the effects of the etonogestrel subdermal implant and depot medroxyprogesterone acetate injection on menstrual bleeding patterns and uterine artery Doppler indices among women seeking interval contraception. A total of 152 eligible women aged 20 to 40 years attending the Family Planning OPD of Dr Baba Saheb Ambedkar Hospital New Delhi will be enrolled and randomized in a one to one ratio to receive either the etonogestrel implant or depot medroxyprogesterone acetate injection. Participants will be followed for six months. Menstrual bleeding patterns will be recorded and uterine artery Doppler indices including pulsatility index resistance index and endometrial thickness will be measured at baseline three months and six months. The study aims to evaluate differences in bleeding patterns and Doppler changes between the two contraceptive methods and to assess side effects acceptability and reasons for discontinuation. |