Clinical trial NCT01452503: Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6
Official title: Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: University of Witwatersrand, South Africa
First posted: 2011-10-17
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Evaluation of preference for three female condoms (FC).

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 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.

Primary outcomes:
measure: Preference of female condom by type
timeFrame: 3 months
Secondary outcomes:
measure: Safety of each of the female condom types
timeFrame: 3 months
measure: Function of each of the female condom types
timeFrame: 3 Months
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: Commercial City Clinic Department of Health
Study officials:
affiliation: RHRU
name: Mags Beksinska, MSc. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.