| CTRI Number |
CTRI/2024/04/066405 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
A Study of adverse drug reactions in female subjects using oral contraceptive pills. |
|
Scientific Title of Study
|
A Prospective observational study for estimation of the adverse drug reactions in female subjects using oral contraceptive pills. |
| 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 Aishwarya Dhakne |
| Designation |
JR1 MD Pharmacology |
| Affiliation |
Bharati Vidyapeeth deemed to be university medical college, Pune |
| Address |
Bharati vidyapeeth Deemed to be University Medical college, Pune
Obstetrics and gynaecology department ground floor OPD in Bharati hospital, Pune, Maharashtra 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
8698554023 |
| Fax |
|
| Email |
aishwarya.dhakne-mcp@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhagyashri Rajopadhye |
| Designation |
Associate Professor Pharmacology Department |
| Affiliation |
Bharati Vidyapeeth deemed to be university medical college, Pune |
| Address |
Bharati vidyapeeth Deemed to be university Medical College
Department of Pharmacology 1st floor,Pune, Maharashtra 411043.
Pune
MAHARASHTRA
411043
India |
| Phone |
9922451264 |
| Fax |
|
| Email |
bhagyashree.rajopadhye@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagyashri Rajopadhye |
| Designation |
Associate Professor Pharmacology Department |
| Affiliation |
Bharati Vidyapeeth deemed to be university medical college, Pune |
| Address |
Bharati Vidyapeeth deemed to be university medical college
Department of Pharmacology, 1st floor, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9922451264 |
| Fax |
|
| Email |
bhagyashree.rajopadhye@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed to be university Hospital,Pune Maharashtra India, 411043 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aishwarya Dhakne |
Bharati Hospital, Pune Maharashtra, 411043 |
Obstetrics and gynaecology department, ground floor OPD.
Pune
MAHARASHTRA |
8698554023
aishwarya.dhakne-mcp@bharatividyapeeth.edu |
| Dr Aishwarya Dhakne |
Obstetrics and gynaecology department |
Bharati vidyapeeth deemed to be university Hospital, Pune
Pune
MAHARASHTRA |
8698554023
aishwarya.dhakne-mcp@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth deemed to be University Medical college, Pune Institutional Ethics committee DCGI ECR 518 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1]Women of the age group 18-60 years freshly
prescribed OC pills
2]Women using OC pills for at least 1 month
3]Women who can recall ADR events
|
|
| ExclusionCriteria |
| Details |
Women with chronic diseases like Hypertension, DM, Kidney disease and Liver disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the ADRs related to use of OC pills in three months duration |
three months duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the proportion of female subjects using OC pills for contraceptive and non- contraceptive purpose.
To determine the perception of female subjects about OC pills
|
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="193"
Sample Size from India="193"
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)
|
08/05/2024 |
| 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="0"
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 planned to understand the prescribing pattern of oral contraceptive pills and their side effects in a tertiary care hospital and its aim is to estimate the adverse drug reactions in female subjects using oral contraceptive pills. Our research question is what is the percentage of Adverse drug reactions in female subjects consuming OC pills in the duration of three months. Through this study we also want to know oral contraceptive pills non contraceptive uses in polycystic ovarian disease , menstrual disorders , hormone replacement therapy etc. It is a prospective observational study carried out during one year. Patient follow up is done for adverse drug reactions for minimum 3 months. |