Preference Among 3 Female Condoms

This study has been completed.
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Reproductive Health and HIV Research Unit (RHRU) in association with the University of the Witwatersrand in Durban, South Africa.
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01452503
First received: August 19, 2011
Last updated: October 14, 2011
Last verified: October 2011

August 19, 2011
October 14, 2011
May 2007
February 2008   (final data collection date for primary outcome measure)
Preference of female condom by type [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The objective of Part 1 is to familiarize each participant with the use characteristics of the three female condom types in order to minimize learning curve effect in subsequent phases of study. In Part 2, a 'simulated market' will be created in order to determine an unbiased, free choice preference for a particular FC type. Part 3 will detail the reasons for participants' selection/preference of specific FC types.
Same as current
Complete list of historical versions of study NCT01452503 on ClinicalTrials.gov Archive Site
  • Safety of each of the female condom types [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    safety measured by number of particpants with adverse events
  • Function of each of the female condom types [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
    FC function measured by number of female condoms that failed during use (e.g. breakage, slippage and invagination) as self-reported by subjects through coital logs
Same as current
Not Provided
Not Provided
 
Preference Among 3 Female Condoms
Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6

Evaluation of preference for three female condoms.

The primary goal of this study was to identify the female condom most preferred by study participants. This provided USAID with data to make informed decisions regarding female condom purchases. The study was conducted in three parts. The objective of Part 1 was to familiarize each participant with the three FC types, to minimize learning curve effect in subsequent phases of study, and to gather information on participant demographics, FC acceptability, device function, safety, preference for each of the condom types, and use of male condoms during the same time period. The objective of Part 2 was to determine actual, "unstated" and "unbiased" preference for a particular type of FC. The objective of Part 3 was to identify reasons for preference of a particular FC type and to document details surrounding product use/non-use.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Female Condom
  • Device: Path Female Condom
    comparison between 3 types of female condoms
  • Device: FC2 female condom
    comparison between 3 types of female condoms
  • Device: Medtech female condom
    comparison between 3 types of female condoms
  • Active Comparator: A
    PATH Women's Condom
    Intervention: Device: Path Female Condom
  • Active Comparator: B
    Female Health Company's FC2 female condom
    Intervention: Device: FC2 female condom
  • Active Comparator: C
    MedTech's Reddy 6 female condom (Commercially known as the V-Amour female condom)
    Intervention: Device: Medtech female condom
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
April 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All women enrolled in this research must meet the following selection 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 not be a sex worker
    7. must not be pregnant (as determined by pregnancy testing) or planning a pregnancy during the time of the research study
    8. must not be breastfeeding
    9. must be without evidence of STI as determined through syndromic diagnosis and vaginal examination
    10. 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)
    11. must not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms
    12. must be willing to give informed consent
    13. must be able to complete condom use log
    14. must be willing to use the study condoms as directed
    15. must be willing to adhere to the follow-up schedule and all study procedures
    16. 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.)
    17. must be willing to provide research study staff with an address, phone number or other locator information while participating in the study
    18. must be willing to participate in the study for up to six months
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT01452503
9928, USAID
No
FHI 360
FHI 360
  • United States Agency for International Development (USAID)
  • Reproductive Health and HIV Research Unit (RHRU) in association with the University of the Witwatersrand in Durban, South Africa.
Principal Investigator: Mags Beksinska, BSc, MSc. PhD RHRU
FHI 360
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP