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

Study Overview
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Brief Summary
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Evaluation of preference for three female condoms (FC).

Detailed Description
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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.

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

Conditions
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Contraception

Intervention / Treatment
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* Device: Path Women's Condom
* Device: FC2 female condom
* Device: Reddy 6 female condom (V-Amour)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women enrolled in this research must meet the following selection criteria: must be at least 18 years of age. must be literate (able to read a newspaper or letter easily). 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). must be in an exclusive (monogamous) sexual relationship with her spouse or partner while participating in this research study. must have been in a sexual relationship with this partner for at least 6 months. must be without evidence of STI as determined through syndromic diagnosis and vaginal examination. 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). must be willing to give informed consent. must be able to complete condom use log. must be willing to use the study condoms as directed. must be willing to adhere to the follow-up schedule and all study procedures. 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.). must be willing to provide research study staff with an address, phone number or other locator information while participating in the study. must be willing to participate in the study for up to six months. Exclusion Criteria: must not be a sex worker. must not be pregnant (as determined by pregnancy testing) or planning a pregnancy during the time of the research study. must not be breastfeeding. must not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PATH Women's Condom<br>PATH Women's Condom | Device: Path Women's Condom<br>* comparison between 3 types of female condoms<br>|
| Active Comparator: FC2 female condom<br>Female Health Company's FC2 female condom | Device: FC2 female condom<br>* comparison between 3 types of female condoms<br>|
| Active Comparator: Reddy 6 female condom (V-Amour)<br>Reddy 6 female condom (Commercially known as the V-Amour female condom) | Device: Reddy 6 female condom (V-Amour)<br>* comparison between 3 types of female condoms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of each of the female condom types | safety measured by number of particpants with adverse events | 3 months | 
| 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 | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IRB Institutional Review Board, IU International units, mg milligram(s), mm3 cubic millimeter(s), PCR polymerase chain reaction, 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, SAE serious adverse event, µg microgram, ULN upper limit of the normal range, WB Western Blot