Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6
NCT ID: NCT01452503
Last Updated: 2023-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
170 participants
INTERVENTIONAL
2007-05-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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PATH Women's Condom
PATH Women's Condom
Path Women's Condom
comparison between 3 types of female condoms
FC2 female condom
Female Health Company's FC2 female condom
FC2 female condom
comparison between 3 types of female condoms
Reddy 6 female condom (V-Amour)
Reddy 6 female condom (Commercially known as the V-Amour female condom)
Reddy 6 female condom (V-Amour)
comparison between 3 types of female condoms
Interventions
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Path Women's Condom
comparison between 3 types of female condoms
FC2 female condom
comparison between 3 types of female condoms
Reddy 6 female condom (V-Amour)
comparison between 3 types of female condoms
Eligibility Criteria
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Inclusion Criteria
1. must be at least 18 years of age.
2. must be literate (able to read a newspaper or letter easily).
3. must be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrollment).
4. must be in an exclusive (monogamous) sexual relationship with her spouse or partner while participating in this research study.
5. must have been in a sexual relationship with this partner for at least 6 months.
6. must be without evidence of STI as determined through syndromic diagnosis and vaginal examination.
7. must be on hormonal or other non-barrier contraception (e.g. OCs, injectables, IUD, or have had a tubal sterilization or be post-menopausal-defined as 12 months with no period).
8. must be willing to give informed consent.
9. must be able to complete condom use log.
10. must be willing to use the study condoms as directed.
11. must be willing to adhere to the follow-up schedule and all study procedures.
12. must have successfully completed a given phase of study before advancing into subsequent phases (e.g. successfully completing Part 1 before advancing to Part 2, etc.).
13. must be willing to provide research study staff with an address, phone number or other locator information while participating in the study.
14. must be willing to participate in the study for up to six months.
Exclusion Criteria
2. must not be pregnant (as determined by pregnancy testing) or planning a pregnancy during the time of the research study.
3. must not be breastfeeding.
4. must not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms.
18 Years
FEMALE
Yes
Sponsors
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United States Agency for International Development (USAID)
FED
University of Witwatersrand, South Africa
OTHER
FHI 360
OTHER
Responsible Party
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Principal Investigators
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Mags Beksinska, MSc. PhD
Role: PRINCIPAL_INVESTIGATOR
RHRU
Locations
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Commercial City Clinic Department of Health
Durban, , South Africa
Countries
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References
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Beksinska M, Smit J, Joanis C, Hart C. Practice makes perfect: reduction in female condom failures and user problems with short-term experience in a randomized trial. Contraception. 2012 Aug;86(2):127-31. doi: 10.1016/j.contraception.2011.11.071. Epub 2012 Jan 20.
Other Identifiers
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USAID
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
9928
Identifier Type: -
Identifier Source: org_study_id
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