| CTRI Number |
CTRI/2024/07/071211 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of The Effect of Implant and injectable contraceptive on Menstrual Pattern |
|
Scientific Title of Study
|
Comparison of The Effect of Etonogestrel Subdermal Single Rod Implant and Depot Medroxyprogesterone Acetate on Menstrual Pattern: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha R |
| Designation |
Post graduate Resident |
| Affiliation |
Lady Hardinge medical college and Associated hospitals |
| Address |
Room no. 266 FAMILY PLANNING OPD, 2nd floor, NEW OPD block. Department of OBGY.
Lady Hardinge medical college associated hospitals, Connaught place.
New Delhi
DELHI
110001
India |
| Phone |
9996636340 |
| Fax |
|
| Email |
nishahcs@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meenakshi |
| Designation |
Professor |
| Affiliation |
Lady Hardinge medical college and Associated hospitals |
| Address |
Room no. 266 FAMILY PLANNING OPD, 2nd floor, NEW OPD block. Department of OBGY.
Lady Hardinge medical college associated hospitals, Connaught place.
New Delhi
DELHI
110001
India |
| Phone |
9560511155 |
| Fax |
|
| Email |
drmeenakshisingh99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meenakshi |
| Designation |
Professor |
| Affiliation |
Lady Hardinge medical college and Associated hospitals |
| Address |
Room no. 266 FAMILY PLANNING OPD, 2nd floor, NEW OPD block. Department of OBGY.
Lady Hardinge medical college associated hospitals, Connaught place.
DELHI
110001
India |
| Phone |
9560511155 |
| Fax |
|
| Email |
drmeenakshisingh99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge medical college and associated hospitals, Connaught place, New Delhi -110001 |
|
|
Primary Sponsor
|
| Name |
Nisha R |
| Address |
Lady Hardinge medical college and associated hospitals, Connaught place, New Delhi -110001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Meenakshi |
Lady Hardinge medical college and associated hospitals, Connaught place, New Delhi -110001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nisha R |
Lady Hardinge medical college and associated hospitals |
Lady Hardinge medical college and associated hospitals, Connaught place, New Delhi -110001
New Delhi
DELHI |
9996636340
nishahcs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lady Hardinge Medical College and Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventing unwanted pregnancies |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Depot medroxy progesterone acetate |
Women will receive 150 mg intramuscular Depot medroxy progesterone acetate injections every 3 monthly. Menstrual pattern will be studied after 3 months of intervention. |
| Intervention |
Etonogestrel single rod subdermal implant |
Women will receive Subdermal Implant insertion containing of 68 mg etonogestrel for 3 years.
Menstrual pattern will be studied after 3 months of intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Willing to participate in the study and for follow up at 3 months.
2. Age group of 18-40 years
3. Desire a highly effective temporary method of contraception
|
|
| ExclusionCriteria |
| Details |
1.Undiagnosed genital bleeding
2.Less than 6 weeks postpartum
3.Active thrombophlebitis or thromboembolic disease
4. Acute liver disease, benign or malignant liver tumors
5. Known or suspected breast cancer
6.Women with known case of depression or other mental Health disorder
7.On drugs induced by liver enzymes or drugs that interfere with coagulation
8.Severe cardiovascular disease
9.Severe hirsutism
10.Any skin infection at the local site of the proposed injection
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of women with changed menstrual patterns (bleeding/spotting episodes, prolonged bleeding, frequent bleeding, infrequent bleeding, irregular bleeding and amenorrhea, as per FIGO criteria) at 3 months follow up in women initiated on Etonogestrel single rod Subdermal Implant and Depot-Medroxyprogesterone Acetate Injection. |
3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Proportion of women with side effects (pain at site of insertion/ injection, headache, dizziness, mood swings, weight gain, breast pain, abdominal pain, any other) in arm A and B assessed at 3 months of use.
2. Proportion of women very unsatisfied, unsatisfied, neutral, satisfied, very satisfied in arm A and B assessed at 3 months of use.
3. Proportion of women who chose to continue the current contraceptive method at 3 months of follow up in arm A and B.
4. Proportion of women who became pregnant during the use of the chosen method at 3 months of use in arm A and B.
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/08/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nishahcs@gmail.com].
- For how long will this data be available start date provided 25-01-2026 and end date provided 20-06-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Both Etonogestrel single rod subdermal implant and DMPA have high efficacy, least failure rates and user friendly temporary contraceptive methods but discontinued most commonly due to menstrual irregularities. There is paucity of studies comparing the above two progesterone based long acting reversible contraceptive (LARC) methods.Both methods are freely available by GoI, studies comparing the two methods may help counselling the women opting for either of the two methods and increase the acceptance and continuation rate. Using sequential computer-generated block randomization study participants will be divided into two arms, arm A and arm B, with 1:1 allocation ratio ARM A: Women will receive Subdermal etonogestrel Implant insertion. ARM B: Women will receive intramuscular DMPA injections. Subjects in both the arms will be given PBAC charts for 90 days for tracking bleeding patterns in these females. The subjects will be followed at 3 months after contraceptive administration. They will be assessed for general and physical examination and menstrual changes will be assessed with PBAC charts. If female has disturbed menstrual pattern or amenorrhea, UPT will be done. Women in both arms will be assessed for side effects, satisfaction, willingness to continue the current method of contraception and failure rate.
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