| CTRI Number |
CTRI/2019/06/019490 [Registered on: 03/06/2019] Trial Registered Prospectively |
| Last Modified On: |
24/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to study the effect of Norethisterone CR Tablets in Women with Heavy Menstrual Bleeding / Abnormal Uterine bleeding. |
|
Scientific Title of Study
|
A Phase III, Multi-center, Prospective, Randomized, Double Blind, Single Dummy, Active Controlled, Comparative Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Norethisterone CR Tablets 15 mg versus Norethisterone Tablets 5 mg to Arrest Bleeding in Women with Heavy Menstrual Bleeding (HMB) / Abnormal Uterine bleeding (AUB) due to Hormonal Imbalance. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CR/CT/18/006 |
Protocol Number |
| Version No. 02, Dated Dec 04, 2018 |
Other |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Isukapalli Vani |
| Designation |
Professor & HOD |
| Affiliation |
Government Medical College & Government General Hospital (Old RIMSGGH) |
| Address |
Department of Gynaecology, Government Medical College & Government General Hospital (Old RIMSGGH)
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8942279033 |
| Fax |
|
| Email |
drivaniggh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhinav Arora |
| Designation |
Managing Director |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd. Drug Regulatory Affairs,
Plot No. 14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar
New Delhi
DELHI
110087
India |
| Phone |
9811882440 |
| Fax |
|
| Email |
abhinavarora@synokempharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhinav Arora |
| Designation |
Managing Director |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd. Drug Regulatory Affairs,
Plot No. 14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar
New Delhi
DELHI
110087
India |
| Phone |
9811882440 |
| Fax |
|
| Email |
abhinavarora@synokempharma.com |
|
|
Source of Monetary or Material Support
|
| Synokem Pharmaceuticals Ltd
14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India |
|
|
Primary Sponsor
|
| Name |
Synokem Pharmaceuticals Ltd |
| Address |
Synokem Pharmaceuticals Ltd 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar,
New Delhi-110087, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Anitha |
Gandhi Hospital |
In-Patient Block, Dept. of Obstetrics and Gynaecology, Gandhi Hospital, Musheerabad, Secunderabad-500003
Hyderabad
TELANGANA |
9440441442
anitasiddu11@gmail.com |
| Dr Moushmi Parpillewar |
Government Medical College & Hospital |
Department of Obstetrics & Gynaecology, Government Medical College & Hospital, Medical College Square, Hanuman Nagar, Nagpur-440003
Nagpur
MAHARASHTRA |
9823232819
drmoushmi@yahoo.co.in |
| Dr Seema Upadhyay |
GSVM Medical College |
Department of Obstetrics & Gynaecology, GSVM Medical College, Swaroop Nagar, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH |
9455635389
seema993573@gmail.com |
| Dr Archana Sinha |
Indira Gandhi Institute of Medical Sciences |
Department of Obstetrics and Gynaecology, Indira Gandhi Institute of Medical Sciences, Sheikhpura,
Patna-800014
Patna
BIHAR |
9661599099
dr.sushant@ymail.com |
| Dr Tapasi Pati |
Institute of Medical Science (IMS) and SUM Hospital |
Department of Obstetrics and Gynaecology, Institute of Medical Science (IMS) and SUM Hospital, SOA University, K8, Kalinga Nagar, Bhubaneswar-751003
Khordha
ORISSA |
9337251682
tapasipati@soauniversity.ac.in |
| Dr Sonali Girish Varsat |
Janam Multi-Specialty Hospital |
Department of Gynaecology,
Janam Multi-Specialty Hospital, Madhav Complex, Near Sanand Police Station, Sanand, Ahmadabad
Ahmadabad
GUJARAT |
8980036411
janamhospital11@gmail.com |
| Dr Sirisha Paidi |
King George Hospital |
Department of Obstetrics & Gynaecology,
King George Hospital, Andhra Medical College, Visakhapatnam-530002
Visakhapatnam
ANDHRA PRADESH |
9885878897
siree_swapna@yahoo.com |
| Dr Sujata Deo |
King Georges Medical University |
Department of Gynaecology, King Georges Medical University chowk, Lucknow-226003
Lucknow
UTTAR PRADESH |
9415152570
drsujata.2008@rediffmail.com |
| Dr Madhavender Jain |
Maharaja Agrasen Superspeciality Hospital |
Department of Gynaecology,
Maharaja Agrasen Superspeciality Hospital,
Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar,
Jaipur-302039, Rajasthan
Jaipur
RAJASTHAN |
9413062961
madhvanderjain@gmail.com |
| Dr Isukapalli Vani |
Rajiv Gandhi Institute of Medical Sciences & RIMS Government Genera! Hospital |
Department of Gynaecology,
Rajiv Gandhi Institute of Medical Sciences &
RIMS Government General Hospital,
Srikakulam-532001
Srikakulam
ANDHRA PRADESH |
8942279033
drivaniggh@yahoo.com |
| Dr Amol Jayant Tilve |
Redkar Hospital and Research Centre |
Redkar Hospital and Research Centre, Mumbai-Goa Highway, Oxelbag, Village-Dhargal, Tal-Pernem-403513
North Goa
GOA |
9158592177
redkar.research@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee, G.S.V.M Medical College |
Approved |
| Institutional Ethics Committee, Gandhi Medical College/Gandhi Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Government Medical College |
Submittted/Under Review |
| Institutional Ethics Committee, Indira Gandhi Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Institute of Medical Sciences (IMS) and SUM Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, King George Hospital |
Approved |
| Institutional Ethics Committee, KIng Georges Medical University |
Submittted/Under Review |
| Institutional Ethics Committee, Maharaja Agrasen Superspecialty Hospital |
Approved |
| Institutional Ethics Committee, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital |
Approved |
| Institutional Ethics Committee, Redkar Hospital and Research Center |
Approved |
| Medilink Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N938||Other specified abnormal uterine and vaginal bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Norethisterone CR Tablets 15 mg |
Norethisterone CR Tablets 15 mg once daily along with placebo (similar to Norethisterone CR Tablets 15 mg) twice daily orally for 84 days |
| Comparator Agent |
Norethisterone Tablets 5 mg |
Norethisterone Tablets 5 mg thrice daily orally for 84 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Female patients of age 25-45 years (both inclusive)
Patients having known history and current signs / symptoms of Abnormal Uterine Bleeding / Heavy Menstrual Bleeding
Patients willing to give written informed consent and comply with the study procedure
|
|
| ExclusionCriteria |
| Details |
1. Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia (or unstable angina) within the last 6 months.
2. Patients with uncontrolled (blood sugar levels specified above) or complicated diabetics including diabetic retinopathy, diabetic neuropathy or diabetic nephropathy)
3. Patients with bleeding disorders and patients with active peptic ulceration.
4. Patients with any major psychiatric disorders (including Schizophrenia or depression) not well controlled with treatment.
5. History of non- compliance to medical regimens or those patients unwilling to comply with the study protocol.
6. Pregnant or breast-feeding women.
7. Patients taking other medicines, including those available to buy without a prescription, herbal and complementary medicines.
8. Patient with known allergic to study medication.
9. Patients with intra uterine contraceptive devices.
10. Patients with epilepsy, high blood pressure, asthma, pulmonary embolism & deep vein thrombosis, hardness or lumps in the breasts, history of breast cancer, hepatic, renal or any other condition according to the investigator may affect the conduct and result of the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean reduction in blood loss during menstruation will be assessed using Pictorial Blood Loss Assessment Chart (PBAC) Score |
At Day 28, Day 56 and Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage Responder (Subject with score ≤100 will be considered as responder) |
At Day 28, Day 56 and Day 84 |
| Changes in bleeding pattern post treatment as compared to baseline |
At Day 28, Day 56 and Day 84 |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
Final Enrollment numbers achieved (Total)= "172"
Final Enrollment numbers achieved (India)="172" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/06/2019 |
| Date of Study Completion (India) |
24/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Phase III, Multi-center, Prospective, Randomized,
Double Blind, Single Dummy, Active Controlled, Comparative Clinical Study.
Study will enroll 162 patients with Heavy
Menstrual Bleeding (HMB) / Abnormal Uterine bleeding (AUB) due to Hormonal
Imbalance from the different centers in India.
Patients will be
recruited after providing written informed consent. After screening, patients
will be randomized (meeting all inclusion & none of the exclusion criteria)
in 1:1 ratio to receive either Norethisterone CR Tablets 15 mg once daily along
with Placebo Tablets (similar to Norethisterone CR Tablets 15 mg) twice daily or
Norethisterone Tablets 5 mg three times daily for 84 days. The primary efficacy
endpoint of the study is mean reduction in blood loss during menstruation will
be assessed using Pictorial Blood Loss Assessment Chart (PBAC) Score. Secondary
efficacy endpoint includes percentage Responder (Subject with score ≤100 will
be considered as responder) and changes in bleeding pattern post treatment as
compared to baseline. During the study, there will be 5 study visits for
efficacy, safety and tolerability assessment. |