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

This study has been completed.
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
University of Witwatersrand, South Africa
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01452503
First received: August 19, 2011
Last updated: May 23, 2016
Last verified: May 2016
History of Changes
  Purpose
Evaluation of preference for three female condoms (FC).

Condition Intervention
Contraception
 Device: Path Women's Condom
Device: FC2 female condom
Device: Reddy 6 female condom (V-Amour)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6

Further study details as provided by FHI 360:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Enrollment: 170
Study Start Date: May 2007
Study Completion Date: April 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PATH Women's Condom
PATH Women's Condom
 Device: Path Women's Condom
comparison between 3 types of female condoms
Active Comparator: FC2 female condom
Female Health Company's FC2 female condom
 Device: FC2 female condom
comparison between 3 types of female condoms
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)
comparison between 3 types of female condoms

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.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
    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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452503

Locations
South Africa
Commercial City Clinic Department of Health
Durban, South Africa, 4001
Sponsors and Collaborators
FHI 360
United States Agency for International Development (USAID)
University of Witwatersrand, South Africa
Investigators
Principal Investigator: Mags Beksinska, MSc. PhD RHRU
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01452503     History of Changes
Other Study ID Numbers: 9928  USAID 
Study First Received: August 19, 2011
Last Updated: May 23, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by FHI 360:
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

ClinicalTrials.gov processed this record on September 27, 2016