| CTRI Number |
CTRI/2023/04/051568 [Registered on: 12/04/2023] Trial Registered Prospectively |
| Last Modified On: |
30/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Ormeloxifene versus Tranexamic acid in the management of abnormal uterine bleeding in reproductive age group women - a randomized control trial |
|
Scientific Title of Study
|
Comparison of Ormeloxifene versus Tranexamic acid in the management of abnormal uterine bleeding in reproductive age group women - a randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavithra S |
| Designation |
1st year Post Graduate resident |
| Affiliation |
Indira Gandhi Medical College and Research Institute |
| Address |
Indira Gandhi Medical College and Research Institute
Department of Obstetrics and
Gynaecology
OPD no.9
Pondicherry
PONDICHERRY
605 009
India |
| Phone |
7010906577 |
| Fax |
|
| Email |
pavithrasankar269@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananthi K |
| Designation |
Professor in Department of Obstetrics and Gynaecology |
| Affiliation |
Indira Gandhi Medical College and Research Institute |
| Address |
Indira Gandhi Medical College and Research Institute, Department of Obstetrics and Gynaecology, OPD NO.9
Pondicherry
PONDICHERRY
605 009
India |
| Phone |
9442992958 |
| Fax |
|
| Email |
ananthiray@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pavithra S |
| Designation |
1st year Post Graduate resident |
| Affiliation |
Indira Gandhi Medical College and Research Institute |
| Address |
Indira Gandhi Medical College and Research Institute
Puducherry
Department of Obstetrics and gynecology
OPD No 9
Pondicherry
PONDICHERRY
605 009
India |
| Phone |
7010906577 |
| Fax |
|
| Email |
pavithrasankar269@gmail.com |
|
|
Source of Monetary or Material Support
|
| INDIRA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
|
|
Primary Sponsor
|
| Name |
INDIRA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
KATHIRKAMAM,VAZHUDAVOOR ROAD ,PONDICHERRY |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Pavithra |
Indira Gandhi Medical College and Research Institute |
OPD No 9
Department of Obstetrics and Gynecology
Kathirkamam
Puducherry
Pondicherry
PONDICHERRY |
7010906577
pavithrasankar269@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: N939||Abnormal uterine and vaginal bleeding, unspecified, (2) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, (3) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tab. Ormeloxifene
|
60 mg
twice a week
orally
for 3 months
followed by
60mg once a week for 3 months
|
| Comparator Agent |
Tab. Tranexamic acid |
500 mg
three times a day
orally
during periods
for 6 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 25-44 years with complaints of menorrhagia and willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2,Women who have delivered within the last 1 year
3.Women who have had abortions in the past 3 months
4.Any drug allergy
5.Post menopausal women
6.Fibroid
7.Adenomyosis
8.Endometriosis
9.Cervical dysplasia
10.Endometrial hyperplasia with atypia
11.Thyroid disorders
12.Breast and genital malignancies
13.Hepatic and renal dysfunction
14.Patient already on antifibrinolytic therapy
15.Patient already on any hormonal therapy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the PBAC score of patients after treatment with Ormeloxifene and Tranexamic Acid |
At the time of recruitment to study , 3rd and 6th month after starting treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Effect on blood hemoglobin levels
2.Need for change of therapy while on the intervention
3.To assess for adverse effects of either drugs
|
At the time of recruitment to study , 3rd and 6th month after starting treatment |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
18/04/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study is to assess the utility of Tab .Ormeloxifene over Tab .Tranexamic acid in the control of menorrhagia with fewer side effects. Objectives of the study is to compare the efficacy, to compare the mean Pictorial blood loss assessment chart scores, effect of hemoglobin levels in the two groups , to compare adverse effects, to assess the need for change of therapy between Ormeloxifene versus Tranexamic acid.This study is a randomized control trial conducted in the department of obstetrics and Gynecology at IGMC&RI among reproductive age group women who present to OPD with menorrhagia . A detailed history will be elicited with regard to demography, complaints, past obstetrics history, medical and surgical history, detailed menstrual history ,clinical examination , necessary investigations and PBAC scoring will be done to assess the menstrual blood loss. PBAC score more than 100 denotes menorrhagia. Participants meeting inclusion criteria and willing to participate in the study , after getting consent subjects will be randomized into either of two groups. Group A will be given Tab .Ormeloxifene 60mg twice a week for 3 months followed by once a week for 3 months . Group B will be given Tab. Tranexamic acid 500mg TDS during periods .Patients will be advised to report immediately if they do not respond to therapy. Follow up will be done at 3rd and 6th month. At each visit PBAC score, Hb, ET will be measured to assess the efficacy of the two groups. |