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CTRI Number  CTRI/2015/07/005996 [Registered on: 14/07/2015] Trial Registered Retrospectively
Last Modified On: 12/07/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Use of female condoms among women in Pune, India  
Scientific Title of Study   Evaluation of uptake and utilization of female condoms among women in Pune, India  
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Smita Joshi 
Designation  Senior Scientist 
Affiliation  Prayas 
Address  Prayas, Amrita Clinic, Athawale Corner, Karve Road Corner, Deccan GYmkhana, Pune
Same as above
Pune
MAHARASHTRA
411004
India 
Phone  919881132506  
Fax  02025420337  
Email  smitanjoshi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Smita Joshi 
Designation  Senior Scientist 
Affiliation  Prayas 
Address  Prayas, Amrita Clinic, Athawale Corner, Karve Road Corner, Deccan GYmkhana, Pune
Same as above
Pune
MAHARASHTRA
411004
India 
Phone  919881132506  
Fax  02025420337  
Email  smitanjoshi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Smita Joshi 
Designation  Senior Scientist 
Affiliation  Prayas 
Address  Prayas, Amrita Clinic, Athawale Corner, Karve Road Corner, Deccan GYmkhana, Pune
Same as above
Pune
MAHARASHTRA
411004
India 
Phone  919881132506  
Fax  02025420337  
Email  smitanjoshi@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, New Delhi, India 
 
Primary Sponsor  
Name  Prayas 
Address  Amrita Clinic, Athawale Corner, Karve Road Corner, Deccan Gymkhana, Pune, Maharashtra 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Smita Joshi  Prayas  Amrita CLinic, 3rd floor, Athawale Corner, Karve Road Corner, Deccan Gymkhana, Pune
Pune
MAHARASHTRA 
919881132506
02025420337
smitanjoshi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Women between 18 and 30 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Female condom   Female condoms by HLL Lifecare Ltd 
Comparator Agent  Not applicable, single arm trial  Not applicable, single arm trial 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  1. Young sexually active women in the reproductive age group from 18 to 30 years who are not using any spacing method
2. Women who are sexually active with at least 1 sex act in the past month
3. History of a menstrual period within 28 days of enrollment
 
 
ExclusionCriteria 
Details  1. Any allergy to latex for either partner
2. Women who are sterilized, those who are using OC pills or CuT
3. Use of any other contraceptive method
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
No of pregnancy events in women using female condoms as a contraceptive  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Acceptability of female condoms among users  12 months 
 
Target Sample Size   Total Sample Size="320"
Sample Size from India="320" 
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="400" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   09/07/2015 
Date of Study Completion (India) 31/08/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Unintended pregnancies, sexually transmitted infection (STI) and HIV remain major personal and public health issues not only in India but the world although their relative priorities vary from region to region. Barrier contraceptives which include male and female condom have the potential to simultaneously avert all of these and thus would be the ideal multipurpose technology (MPT) to improve reproductive health. Male condoms have been widely promoted  and their correct and consistent use can also protect women against HIV, STIs and unintended pregnancies, however its use requires cooperation of the male partner and females do not have much control over its use. In India, male condoms are widely available and are inexpensive yet they are used by only 5% of the population. Female condoms have been available in India for quite some time however they are known to only to minority. Very few studies have examined the acceptability of female condoms in India and no study has yet explored its uptake, acceptability and utilization as a spacing technology where there is a huge unmet need of contraception which is addressed in this proposal.   

 
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