| CTRI Number |
CTRI/2024/03/064357 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two drugs for a treatment |
|
Scientific Title of Study
|
Comparison of the effectiveness of depo-medroxyprogesterone (DMPA)+Atorvastatin (combination) Vs DMPA in the treatment of adenomyosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maitrayee sen |
| Designation |
Associate Professor |
| Affiliation |
SRM Institution |
| Address |
Department of OBG
SRM Medical College and Hospital
SRMIST, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884041591 |
| Fax |
|
| Email |
dr.maitrayee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Sriram |
| Designation |
Assistant Professor |
| Affiliation |
SRM INSTITUTION |
| Address |
SRM College of Pharmacy
SRMIST, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8012345507 |
| Fax |
|
| Email |
srirama1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SK NITHYASHREE |
| Designation |
Student |
| Affiliation |
SRM INSTITUTION |
| Address |
F5, No.13, 40th Street
Nanganallur
F5, No. 13, 40th Street
Nanganallur
Chennai
TAMIL NADU
600061
India |
| Phone |
07598830168 |
| Fax |
|
| Email |
nithyashree861@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM College of Pharmacy
SRMIST, Potheri SRM Nagar, Kattankulathur, Tamil Nadu 603203 |
|
|
Primary Sponsor
|
| Name |
SRM college of pharamacy |
| Address |
SRMIST, Kattankulathur
Potheri SRM Nagar |
| Type of Sponsor |
Research institution |
|
|
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 |
| Maitrayee sen |
SRM Institution |
Department of OBG
SRM Medical College and Hospital
SRMIST, Kattankulathur
Kancheepuram
TAMIL NADU |
09884041591
dr.maitrayee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRMIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DMPA |
150mg once in 3 months (IM) |
| Intervention |
DMPA + Atorvastatin |
DMPA - 150mg (IM) once in 3 months, Atorvastatin: 20 mg once daily |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
patients diagnosed with adenomyosis in ultrasonography
patients willing to participate
patient willing to be on contraceptives during study period |
|
| ExclusionCriteria |
| Details |
patients planning for pregnancy
pregnant and lactating patients
patients with mental illness
patients who are already in any other hormonal treatment for adenomyosis
patients who have undergone surgery (less than 6 months)
patients diagnosed with mild hepatic dysfunction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the change in pain as measured by Wong Bakers FACES pain rating scale in patients receiving DMPA + Atorvastatin and DMPA alone
To assess the change in abnormal uterine bleeding as measured by the UFS-QOL questionnaire in patients receiving DMPA + Atorvastatin and DMPA alone |
Patients will be followed at the end of 4, 8 and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the change in uterine volume and vascularity by measuring the pulsatility index by transvaginal USG (MUSA criteria)
To assess the quality of life in patients using UFS-QOL questionnaire
To assess the Hb level on day 2 as measured by blood samples in patients with adenomyosis
|
Patients will be followed at the end of 4, 8 and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/03/2024 |
| 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="0"
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-identiļ¬cation.
- 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 - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nithyashree861@gmail.com].
- For how long will this data be available start date provided 25-06-2024 and end date provided 25-08-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a study about comparing 2 drugs in the treatment of adenomyosis. The standard drug is compared with the test drug. Here, the standard drug is DMPA, i.e., DEPO MEDROXY PROGESTRONE, and the test drug is DMPA + ATORVASTATIN (Combination) where the DMPA concentrate on the AUB and ATORVASTATIN helps in reducing the pain and vascularity of the tissue. |