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CompletedNCT01452503Updated Sep 13, 2023

Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6

An interventional study of Path Women's Condom and FC2 female condom in Contraception, sponsored by FHI 360. Completed at 1 site in South Africa. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by FHI 360 · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Evaluation of preference for three female condoms (FC).

Read the detailed description

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.

02

Conditions studied

  • Contraception

Keywords

  • AE adverse event
  • AIDS acquired immunodeficiency syndrome
  • ALT (SGPT) alanine aminotransferase
  • ART antiretroviral therapy
  • AST (SGOT) aspartate aminotransferase
  • DCF data collection forms
  • DMC Data Monitoring Committee
  • FDA (U.S.) Food and Drug Administration
  • GCP Good Clinical Practice guidelines
  • HB sAg Hepatitis B surface antigen
  • ICH International Conference of Harmonization
  • IND Investigational New Drug Application
  • IRB Institutional Review Board
  • IU International units
  • mg milligram(s)
  • mm3 cubic millimeter(s)
  • PCR polymerase chain reaction
  • SAE serious adverse event
  • µg microgram
  • ULN upper limit of the normal range
  • WB Western Blot
03

In context

Lead sponsor

FHI 360 is the lead sponsor of 56 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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 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

  1. must not be a sex worker.

    1. must not be pregnant (as determined by pregnancy testing) or planning a pregnancy during the time of the research study.
    2. must not be breastfeeding.
    3. must not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
170 participants (actual)

Study arms

  • Active comparator
    PATH Women's Condom

    PATH Women's Condom

    Device: Path Women's Condom

  • Active comparator
    FC2 female condom

    Female Health Company's FC2 female condom

    Device: FC2 female condom

  • Active comparator
    Reddy 6 female condom (V-Amour)

    Reddy 6 female condom (Commercially known as the V-Amour female condom)

    Device: Reddy 6 female condom (V-Amour)

Interventions

  • DevicePath Women's Condom

    comparison between 3 types of female condoms

  • DeviceFC2 female condom

    comparison between 3 types of female condoms

  • DeviceReddy 6 female condom (V-Amour)

    comparison between 3 types of female condoms

06

What researchers measure

Primary outcomes

  1. Preference of female condom by type

    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.

    Time frame: 3 months

Secondary outcomes

  1. Safety of each of the female condom types

    safety measured by number of particpants with adverse events

    Time frame: 3 months

  2. Function of each of the female condom types

    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

    Time frame: 3 Months

07

Study locations

1 site
  • Commercial City Clinic Department of Health
    Durban, 4001, South Africa
08

References and documents

Publications

  • 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. PubMed 22264667 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01452503
Lead sponsor
FHI 360
Collaborators
United States Agency for International Development (USAID), University of Witwatersrand, South Africa
Responsible party
Sponsor
First posted
Oct 17, 2011
Start date
May 2007
Primary completion
Feb 2008
Completion
Apr 2008
Last update
Sep 13, 2023

Study contacts

Mags Beksinska, MSc. PhD
principal investigator · RHRU

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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