| 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
|
|
|
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
|
|
|
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. |