| CTRI Number |
CTRI/2024/07/069801 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF THE EFFECTIVENESS OF CENTCHROMAN AND NORETHISTERONE IN THE TREATMENT OF HEAVY MENSTRUAL BLEEDING |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED INTERVENTIONAL STUDY COMPARING THE EFFECTIVENESS OF CENTCHROMAN AND NORETHISTERONE IN THE TREATMENT OF HEAVY MENSTRUAL BLEEDING |
| 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 ANGANA DAS |
| Designation |
MS STUDENT |
| Affiliation |
ESI PGIMSR ESICMCH JOKA KOLKATA |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY ESI PGIMSR ESIC MEDICAL COLLEGE AND HOSPITAL JOKA KOLKATA
South Twentyfour Parganas
WEST BENGAL
700104
India |
| Phone |
8637339281 |
| Fax |
|
| Email |
anganadas50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANISHA BAJAJ |
| Designation |
PROFESSOR AND GUIDE |
| Affiliation |
ESI PGIMSR ESICMCH JOKA KOLKATA |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY ESI PGIMSR ESICMCH JOKA KOLKATA
South Twentyfour Parganas
WEST BENGAL
700104
India |
| Phone |
8902266280 |
| Fax |
|
| Email |
dr.manisha.bajaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANISHA BAJAJ |
| Designation |
PROFESSOR AND GUIDE |
| Affiliation |
ESI PGIMSR ESICMCH JOKA KOLKATA |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY ESI PGIMSR ESICMCH JOKA KOLKATA
South Twentyfour Parganas
WEST BENGAL
700104
India |
| Phone |
8902266280 |
| Fax |
|
| Email |
dr.manisha.bajaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI-PGIMSR ESIC MEDICAL COLLEGE AND HOSPITAL JOKA DIAMOND HARBOUR ROAD KOLKATA 700104 WEST BENGAL INDIA |
|
|
Primary Sponsor
|
| Name |
ANGANA DAS |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY ESI-PGIMSR ESIC MEDICAL COLLEGE AND HOSPITAL JOKA KOLKATA WEST BENGAL INDIA 700104 |
| Type of Sponsor |
Other [SELF] |
|
|
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 ANGANA DAS |
EMPLOYEES STATE INSURANCE POST GRADUATE INSTITUTE OF MEDICAL SCIENCES RESEARCH JOKA |
GYNAECOLOGY OUT PATIENT DEPARTMENT GROUND FLOOR ACADEMIC BUILDING ESI HOSPITAL JOKA
South Twentyfour Parganas
WEST BENGAL |
8637339281
anganadas50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ESI PGIMSR ESIC MEDICAL COLLEGE JOKA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N925||Other specified irregular menstruation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab NORETHISTERONE |
Tab Norethisterone will be given to the subjects in the dose of 5 mg twice daily from day 5 to day 25 of the menstrual cycle for a total of 6 cycles, follow up visits will be done at 2 months, 4 months, 6 months from the start of the treatment. |
| Intervention |
Tablet CENTCHROMAN |
Tab Centchroman to be started as 60 mg twice weekly for the first 3 months followed by 60 mg once weekly for the next 3 months, follow up visits done at 2 months, 4 months, 6 months from the start of treatment. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Women with heavy menstrual bleeding with or without associated dysmenorrhea or chronic pelvic pain
2.All women with histologically proven endometrial hyperplasia without atypia or any other benign endometrial pathology
3.Fibroid uterus less than 12 weeks in size not distorting the endometrial cavity
4.Adenomyosis
5.All women with medical or surgical high risk factors making the subjects unsuitable for surgery |
|
| ExclusionCriteria |
| Details |
1.Active genital infection
2.Suspicion of pregnancy or malignancy
3.Submucosal fibroid distorting the endometrial cavity
4.Uterine fibroids more than 5 centimeters in size
5.Atypical endometrial hyperplasia or malignancy
6.Abnormal cervical cytology and malignancy
7.Haematological disease or abnormal coagulopathy
8.History of arterial or venous thromboembolic disorders
9.Women who want to conceive
10.Women who are not willing to give consent for the study
11.Patients with polycystic ovarian disease or history of jaundice or hepatic impairment or severe allergy or tuberculosis or renal impairment or undiagnosed vaginal bleeding or breast cancer |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy in terms of reduction of menstrual blood loss by PBAC(pictorial blood loss assessment) score calculation before and after treatment with Centchroman and Norethisterone.
|
PBAC score calculation before starting the treatment, at 2 monthly visit, at 4 monthly visit, at 6 monthly visit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the endometrial thickness on Ultrasonography before and after treatment with Centchroman and Norethisterone |
Endometrial thickness (ET) measurement on USG before starting the treatment, at 2 monthly visit, at 4 monthly visit, at 6 monthly visit. |
| To check the mean Hemoglobin levels of the patients before and after treatment with Centchroman and Norethisterone |
Hemoglobin level estimation before starting the treatment, at 2 monthly visit, at 4 monthly visit, at 6 monthly visit. |
| To compare the effect of Centchroman and Norethisterone on the metabolic parameters of the patient (Blood glucose levels, Liver function tests, Serum lipid profile) |
Fasting blood glucose, post-prandial blood glucose, lipid profile, liver function test and glycosylated hemoglobin (HbA1C) level estimation before starting the treatment, at 2 monthly visit , at 4 monthly visit, at 6 monthly visit |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
12/07/2024 |
| 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 - NO
|
|
Brief Summary
|
Heavy menstrual bleeding is a common problem and about one-third females seek treatment for it. Although surgery is the definitive treatment, many methods of medical management are available and newer methods are still in development as it is important to prevent unnecessary surgical intervention and reduce the country’s health expenses. My study aims to determine and compare the efficacy of CENTCHROMAN ( ORMELOXIFENE) and NORETHISTERONE in the treatment of heavy menstrual bleeding. While NORETHISTERONE is widely used for this purpose, CENTCHROMAN is not used routinely for the treatment of heavy menstrual bleeding, rather it was introduced as an oral contraceptive under the family planning program of GOI since 1991. Centchroman has antiestrogenic action which helps in the suppression of endometrial hyperplasia thus can prove to be a wonder drug in the treatment of HMB with its lesser frequent dosing schedule and easy availability. It can be safely used in patients with multiple comorbidities with minimal long term side effects.
After approval of the Institutional Ethics Committee and WBUHS, 90 women between the ages of 35-55 years with biopsy proven no endometrial atypia will be enrolled for the study after informed consent. They will be allocated into 2 groups based on randomization process. Group A subjects will be started on tablet Centchroman whereas Group B subjects will be started on tablet Norethisterone for 6 months. At the start of the treatment, PBAC score, endometrial thickness by USG, Hemoglobin level and metabolic parameters of the patients will be recorded for reference.
They will be asked to come on regular follow up visits for response evaluation. The above parameters will be checked and recorded at 2 monthly, 4 monthly and 6 monthly visits. Patient satisfaction will also be noted.
After completion of the data collection, we will present the statistically significant data between the two groups. |