| CTRI Number |
CTRI/2024/07/070066 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effects of two drugs in the management of abnormal uterine bleeding |
|
Scientific Title of Study
|
Comparative efficacy of combined oral contraceptives and ormeloxifene in the management of abnormal uterine 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 Harmanpreet Kaur |
| Designation |
PG junior resident |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Obstetrics and Gynaecology, Level 4, D block, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8431326368 |
| Fax |
|
| Email |
harmanpreet131999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharti Goel |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Obstetrics and Gynaecology, Level 4, D block, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121606 |
| Fax |
|
| Email |
bhartigoel14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharti Goel |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Obstetrics and Gynaecology, Level 4, D block, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121606 |
| Fax |
|
| Email |
bhartigoel14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Sector Chandigarh India Pincode |
| Address |
Government Medical College and Hospital, Sector 32, Chandigarh, India, Pincode 160030 |
| 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 |
| Dr Harmanpreet Kaur |
Government Medical College and Hospital, Sector 32, Chandigarh, India |
Department of Obstetrics and Gynaecology, Level 4, D block, Government Medical College and Hospital, Sector 32, Chandigarh, India, Pincode 160030
Chandigarh
CHANDIGARH |
8431326368
harmanpreet131999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH, Chandigarh |
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 |
| Comparator Agent |
Combined Oral Contraceptive |
Combined Oral contraceptives will be given as medical treatment to patients diagnosed ultrasonographically with abnormal uterine bleeding due to structural causes. Combined oral contraceptive pill containing ethinyl estradiol 30mcg and levonorgestrel 150mcg will be administered per oral from days 1 to 21 of menstrual cycle for 4 months. Assessment will be made in terms of change in pain score, change in score of pictorial blood assessment charts and patient satisfaction with the treatment at the end of 2 months and 4 months after start of therapy. |
| Intervention |
Ormeloxifene |
Ormeloxifene will be given as medical treatment to patients diagnosed ultrasonographically with abnormal uterine bleeding due to structural causes. The drug will be administered per oral in the dose of 60mg twice a week for 2 months followed by 60mg once a week for the next 2 months. Assessment will be made in terms of change in pain score, change in score of pictorial blood assessment charts and patient satisfaction with the treatment at the end of 2 months and 4 months after start of therapy. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Women presenting to Gynaecological OPD with Abnormal Uterine Bleeding related to structural causes of the uterus, uterine fibroids and adenomyosis |
|
| ExclusionCriteria |
| Details |
1. Women with bulky fibroids presenting with pressure symptoms who are not fit for medical management.
2. Submucosal fibroid type 0 and type 1.
3. Endometrial polyp, endometrial hyperplasia or malignancy.
4. Complex adnexal mass.
5. Acute AUB.
6. Abnormal renal or hepatic function tests.
7. Coagulopathy.
8. History of breast or genital malignancy.
9. Smoking.
10. Thromboembolic disease.
11. Diabetes, hypertension, migraine or epilepsy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in amount and duration of menstrual blood loss by assessing pattern of periods through PBAC (Pictorial blood assessment charts) score. |
At the end of 2 months and 4 months after the start of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in pain score after medication based on NRS (Numerical pain rating score).
2. Patient satisfaction with treatment using TSQM (Treatment satisfaction questionnaire for medication). |
At the end of 2 months and 4 months after the start of treatment. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/07/2024 |
| 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
|
Eligible participants will be recruited after fulfilment of inclusion criteria at the time of first visit to GMCH-32. Patients will be divided into the two treatment groups by use of computer- generated random numbers. Group A will be given a combined oral contraceptive pill containing ethinyl estradiol 30 mcg and levonorgestrel 150mcg on days 1-21 for 4 months. Group B patients will be given ormeloxifene 60 mg twice a week for 2 months followed by 60mg once a week for the next 2 months. In order to conceal allocation, the computer- generated numbers will be delivered to the patients in opaque, sealed envelopes. It will be an open label trial. Detailed history, baseline general examination and complete gynaecological examination will be done for all patients recruited into the study. Assessment of blood loss will be done using PBAC (pictorial blood loss assessment chart) score. Severity of dysmenorrhoea will be graded according to Numerical Pain Rating Scale (NRS). Patient satisfaction with treatment will be assessed using Treatment Satisfaction Questionnaire for medication (TSQM). An ultrasonographic confirmation of presence of fibroid or adenomyosis will be done. Bilateral adnexa will be assessed before beginning the therapy for any cysts in the ovaries or adnexal mass. Blood samples will be collected for investigations including complete hemogram with peripheral blood film, coagulation profile, baseline liver and renal function tests. Follow up will be done at 2 months and 4 months after starting treatment. Note will be made of any side effects observed by the patient such as gastric upset, headache, weight gain, mastalgia etc |