| CTRI Number |
CTRI/2025/02/081131 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Etonogestrel Implant with Levonorgestrel IUD for Endometriosis Treatment in Young Women |
|
Scientific Title of Study
|
Novel use of Etonogestrel
(ETN) Subdermal Implant (SDI) in adolescents and reproductive age group women
with endometriosis and its comparison with Levonogestrel Intra-Uterine System
(LNG-IUS) A non-inferiority prospective pilot study |
| Trial Acronym |
ETN SDI vs LNG-IUS:25 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Varun |
| Designation |
Associate professor, Department of obstetrics and Gynaecology |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Department of obstetrics and Gynaecology Mother and Child Block All India Institute of Medical Sciences Ansari Nagar New Delhi
Department of obstetrics and Gynaecology Mother and Child Block All India Institute of Medical Sciences Ansari Nagar New Delhi
South
DELHI
110029
India |
| Phone |
9873884869 |
| Fax |
|
| Email |
drneha.ucms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Varun |
| Designation |
Associate professor, Department of obstetrics and Gynaecology |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Department of obstetrics and Gynaecology Mother and Child Block All India Institute of Medical Sciences Ansari Nagar New Delhi
Department of obstetrics and Gynaecology Mother and Child Block All India Institute of Medical Sciences Ansari Nagar New Delhi
DELHI
110029
India |
| Phone |
9873884869 |
| Fax |
|
| Email |
drneha.ucms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Varun |
| Designation |
Associate professor, Department of obstetrics and Gynaecology |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Department of obstetrics and Gynaecology Mother and Child Block All India Institute of Medical Sciences Ansari Nagar New Delhi
Department of obstetrics and Gynaecology Mother and Child Block All India Institute of Medical Sciences Ansari Nagar New Delhi
DELHI
110029
India |
| Phone |
9873884869 |
| Fax |
|
| Email |
drneha.ucms@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
AIIMS Campus Temple Ansari Nagar East New delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 Neha Varun |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Department of obstetrics and gynaecology Mother and Child Block AIIMS Ansari Nagar
South
DELHI |
9873884869
drneha.aiims11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N719||Inflammatory disease of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Etonogestrel (ETN) Subdermal Implant (SDI) |
ETN-SDI is found to be very effective long acting reversible
contraceptive method and offers an additional benefit of reduction in pelvic pain. It has the
potential for providing long term treatment of endometriosis in reducing pain as well effect
on progression of disease. |
| Comparator Agent |
Levonogestrel Intra-Uterine System |
The LNG IUS is an excellent option for young women, both as a contraceptive and for
alleviation of endometriosis-associated symptoms. Insertion in nulliparae is usually without
difficulty in more than 80% of cases. [10] Rates of expulsion, bleeding, and amenorrhea in
adolescent users appear to be similar to those reported by older women.[11] However, there
is still some reluctance on the part of clinicians to use the LNG IUS in nulliparous women
and adolescents. Also there are acceptability issues by unmarried/nulliparous girls and their
family members in Indian settings. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients clinically diagnosed with endometriosis (Complains of non-cyclical
chronic pelvic pain and/or dysmenorrhea > 6 months) with either
a) Radiological diagnosis of endometriosis based on TVS and MRI.
b) Surgically and histologically confirmed diagnosis of endometriosis. |
|
| ExclusionCriteria |
| Details |
1. Not willing to participate in the study
2. Any known allergy to progesterone
3. Uterine fibroids
4. Endometrial polyps
5. Cardiovascular, hepatic, renal impairment, or any other contraindications and special
warnings for treatment with Etonogestrel |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of ETN-SDI in reducing endometriosis associated
non-cyclic pain and dysmenorrhea as compared to LNG-IUS. |
VAS SCORE ASSESSMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the acceptability of ETN-SDI in participants (adolescent and reproductive
age women)
2. Health related quality of life at baseline and monthly up to 6 months
3. Vaginal bleeding pattern baseline and monthly up to 6 months
4. To study the effect of ETN-SDI and LNG IUS on BMD at baseline, 12 and 24 months
5. To study the effect of ETN-SDI and LNG IUS on biomarkers like CA-125 (Baseline
and after 6 months)
6. To study the effect of ETN-SDI and LNG IUS on hormones (E2, FSH, LH)- Baseline
and after 6 months
7. Withdrawal rate
8.Overall degree of satisfaction (Likert scale)
9. Any adverse events associated |
1. Health related quality of life: Endometriosis Health profile-30 questionnaire
2. Vaginal bleeding pattern: Assessed using menstrual calendar
3. Effect on BMD: Measuring BMD at spine, femoral head and distal radius of the non-
dominant forearm using dual-energy X-ray absorptiometry.
4. CA-125 measurement
5. Withdrawal rate (Months of continuation will be recorded)
6. Overall degree of satisfaction (Likert scale)
7. E2, FSH, LH measurements
8. Any adverse events associated |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/03/2025 |
| 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="3"
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 project aims to explore the effectiveness of Etonogestrel Subdermal Implant (ETN-SDI) as a treatment for endometriosis-related pain in adolescent and reproductive-age women. Endometriosis, which affects 10-15% of women, often causes significant pelvic pain, dysmenorrhea, and infertility. Currently, available treatments, like combined oral contraceptives (COCs) and LNG-IUS (Levonorgestrel Intra-Uterine System), have limitations, especially in adolescent populations. ETN-SDI, a long-acting contraceptive, has shown promise in reducing pain associated with endometriosis and may offer additional benefits as a reversible contraceptive. The study will compare the efficacy of ETN-SDI and LNG-IUS in reducing endometriosis pain, using a non-inferiority prospective trial with 100 participants. It will also examine factors like acceptability, quality of life, bleeding patterns, and biomarkers such as CA-125 and BMD. Expected outcomes include ETN-SDI as a safe, cost-effective, long-term treatment for endometriosis and an effective contraceptive option. The study could have significant implications for adolescent health by expanding treatment options and addressing both pain and contraception needs in this population. |