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

FHI 360

Status: Completed

Conditions: Contraception

Treatments: Device: Path Women's Condom; Device: Reddy 6 female condom (V-Amour); Device: FC2 female condom

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01452503

9928

USAID (Other Grant/Funding Number)

Details and patient eligibility

About

Evaluation of preference for three female condoms (FC).

Full 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.

Enrollment: 170 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

170 participants in 3 patient groups

PATH Women's Condom

Active Comparator group

Description:

PATH Women's Condom

Treatment:

Device: Path Women's Condom

FC2 female condom

Active Comparator group

Description:

Female Health Company's FC2 female condom

Treatment:

Device: FC2 female condom

Reddy 6 female condom (V-Amour)

Active Comparator group

Description:

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

Treatment:

Device: Reddy 6 female condom (V-Amour)