| CTRI Number |
CTRI/2019/01/017230 [Registered on: 24/01/2019] Trial Registered Prospectively |
| Last Modified On: |
08/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
camparative study of safety and efficacy of Medroxyprogesterone acetate and ormeloxifene in women with Abnormal uterine bleeding: An observational study |
|
Scientific Title of Study
|
PROSPECTIVE OBSERVATIONAL STUDY FOR SAFETY & EFFICACY OF ORMELOXIFENE & MEDROXYPROGESTERONE ACETATE IN WOMEN WITH ABNORMAL UTERINE BLEEDING |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suhail Ahmad Mir |
| Designation |
Student |
| Affiliation |
university of kashmir |
| Address |
Department of Pharmaceutical Sciences
University of kashmir
Hazratbal Srinagar,190006
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006270349 |
| Fax |
|
| Email |
suhailmir.scholar@kashmiruniversity.net |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G N Bader |
| Designation |
ASSISSTANT Professor |
| Affiliation |
university of kashmir |
| Address |
Department of Pharmaceutical Sciences
University of kashmir
Hazratbal Srinagar,190006
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006224042 |
| Fax |
|
| Email |
gbader2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suhail Ahmad Mir |
| Designation |
Student |
| Affiliation |
university of kashmir |
| Address |
Department of Pharmaceutical Sciences
University of kashmir
Hazratbal Srinagar,190006
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006270349 |
| Fax |
|
| Email |
suhailmir.scholar@kashmiruniversity.net |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SKIMS Medical College and Hospital |
| Address |
Bemina Srinagar
Jammu and Kashmir |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Suhail Ahmad Mir |
SKIMS MEDICAL COLLEGE AND HOSPITAL BEMINA SRINAGAR |
GYNE & OBSTETRIC OPD ROOM NO. 1
Department of Obsterics and Gyneacology
Srinagar
JAMMU & KASHMIR |
7006270349
suhailmir.scholar@kashmiruniversity.net |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee Skims Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ormeloxifene and medroxyprogesterone acetate |
Dose and frequency of ormeloxifene is 60mg twice a week for three months, dose and frequency of medroxyprogesterone acetate is 10mg twice a day for 21 days in a month for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All patients diagnosed with AUB attending the OPD/or for consultation in the Obstetrics and Gynaecology department of SKIMS Medical College and Hospital, Bemina, Srinagar will be enrolled during the study period |
|
| ExclusionCriteria |
| Details |
Patients with leiomyoma, adenomyosis, polyp, adnexal mass.
Patients with systemic disorder.
Patients with coagulopathy
Patients with breast malignancy
Patients with endometrial hyperplasia
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the effects of ormeloxifene and medroxyprogesterone acetate in womenn with abnormal uterine bleeding on Heamoglobon, Endometrail thickness and Pictorial blood loss assessment by Complete blood chemistry, USG and PBAC score card respectively |
AFTER 4 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the effects of ormeloxifene and medroxyprogesterone acetate in womenn with abnormal uterine bleeding on Heamoglobon, Endometrail thickness and Pictorial blood loss assessment by Complete blood chemistry, USG and PBAC score card respectively |
monthly follow up upto 4 months |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="240" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/01/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Under process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Abnormal uterine bleeding (AUB) is responsible for significant health problem and social embarrassment and it is one of the common reasons women seek health care. It has a significant impact on the quality of life for the women. Women with abnormal bleeding have a lower quality of life than the general female population (NPH). AUB is a significant clinical entity. AUB and its sub group, heavy menstrual bleeding (HMB), are common conditions affecting 14–25% of women of reproductive age (Fraser et al, 2009) and may have a significant impact on their physical, social, emotional and quality of life. In the UK, over 800,000 women seek help for AUB annually (NICE 2007). The prevalence varies in each country. In India, the reported prevalence of AUB is around 17.9% (NPH). Because of the morbidity associated with the surgical procedures, the Royal College of Obstetricians and Gynaecologists RCOG recommends beginning with medical management before resorting to surgical interventions, but medical management of AUB should relieve symptoms, improve quality of life and avoid the risk of surgery. Ormiloxifene (SERM) is finding a promising role in the treatment and management of AUB. Ormeloxifene has a good patient acceptability and compliance due to its minimal side effects, low cost and simple dosage schedule than that of Medroxyprogesterone (MPA).This study will furnish the necessary information about the use of Ormiloxifene. |