| CTRI Number |
CTRI/2024/12/078353 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, ormeloxifene and Norethisterone acetate in patients with abnormal uterine bleeding |
|
Scientific Title of Study
|
Effectiveness of Ormeloxifene versus Norethisterone acetate for control of bleeding in women with abnormal uterine bleeding– A randomized control 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 |
Vasundhara Wasudeo Gawande |
| Designation |
Junior Resident |
| Affiliation |
Nkp Salve Institute Of Medical Sciences And Research Centre,Nagpur |
| Address |
Nkp Salve Institute Of Medical Sciences And Research Centre
Police Nagar, CRPF road, Digdoh Hills
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9545733947 |
| Fax |
|
| Email |
vwsg98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Varsha Kose |
| Designation |
Associate Professor |
| Affiliation |
NKP SALVE INSTITUE OF MEDICAL SCIENCES AND RESEARCH CENTRE, NAGPUR |
| Address |
Lata Mangeshkar hospital, Hingna road
Police nagar, CRPF road, digdoh hills
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9372304330 |
| Fax |
|
| Email |
varshadkose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vasundhara Wasudeo Gawande |
| Designation |
Junior Resident |
| Affiliation |
Nkp Salve Institute Of Medical Sciences And Research Centre,Nagpur |
| Address |
Nkp Salve Institute Of Medical Sciences And Research Centre
Police Nagar, CRPF road, Digdoh hills
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9545733947 |
| Fax |
|
| Email |
vwsg98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nkp Salve Institute Of Medical Sciences And Research Centre,Nagpur |
|
|
Primary Sponsor
|
| Name |
Vasundhara Wasudeo Gawande |
| Address |
Nkp Salve Institute Of Medical Sciences And Research Centre, Police Nagar, CRPF road, Digdoh hills, Nagpur 440019 |
| Type of Sponsor |
Private 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 |
| Dr Vasundhara Wasudeo Gawande |
Nkp Salve Institute Of Medical Sciences And Research Centre,Nagpur |
Labour room, third floor, Department of Obstetrics and Gynaecology, Police Nagar, CRPF road, Digdoh hills
Nagpur
MAHARASHTRA |
9545733947
vwsg98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E289||Ovarian dysfunction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Norethisterone |
5mg per oral BD 21 days for 6 menstrual cycles |
| Comparator Agent |
Ormeloxifene |
60mg per oral twice a week for 12 weeks followed by once a week for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
47.00 Year(s) |
| Gender |
Female |
| Details |
women willing to keep record of vaginal bleeding and regular follow up |
|
| ExclusionCriteria |
| Details |
PCOS, postmenopausal bleeding, heart disease, genital malignancy, puberty menorrhagia |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| endometrial thickness, blood loss in terms of PBAC |
1month, 3month, 6month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| oligomenorrhea, hypomenrrhea, weight gain, nausea, vomiting |
1month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2024 |
| 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="2"
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
|
This study is a randomized trial to compare the
efficacy of ormeloxifene and norethisterone acetate in women with abnormal
uterine bleeding. •The women will randomly be allocated to 2 groups
of 30 each. Group O will be given Ormeloxifene tablet 60mg stat and Group N will be given Tab
norethisterone acetate 5mg 2tab TDS. We will see for control of bleeding in
both the group. If in any group bleeding is not controlled we will give
tranexamic acid injectable or oral.
After active bleeding controlled we will give in Group O tab Ormeloxifene 60mg twice a week for 12 weeks followed by 60mg once a
week for next 12 weeks. Group N will be given Norethisterone acetate tablet 5mg
twice a day for 21 days for 6 cycles. Follow up will be done at 1, 3, 6 months.
At each visit a detailed menstrual history will be taken, PBAC score will be
calculated. •The primary outcome measures will be reduction
in amount of menstrual blood loss (assessed by fall in PBAC score and patient’s
subjective assessment),hemoglobin concentration and decrease in endometrial
thickness in proliferative phase on transvaginal ultrasound.Secondary outcome measures will be the side effect which will be assessed
at 1month revisit. |