Preference Among 3 Female Condoms
This study has been completed.
Sponsor:
FHI 360
Collaborators:
United States Agency for International Development (USAID)
Reproductive Health and HIV Research Unit (RHRU) in association with the University of the Witwatersrand in Durban, South Africa.
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01452503
First received: August 19, 2011
Last updated: October 14, 2011
Last verified: October 2011
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Purpose
Evaluation of preference for three female condoms.
| Condition | Intervention |
|---|---|
|
Female Condom |
Device: Path Female Condom Device: FC2 female condom Device: Medtech female condom |
| 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: A
PATH Women's Condom
|
Device: Path Female Condom
comparison between 3 types of female condoms
|
|
Active Comparator: B
Female Health Company's FC2 female condom
|
Device: FC2 female condom
comparison between 3 types of female condoms
|
|
Active Comparator: C
MedTech's Reddy 6 female condom (Commercially known as the V-Amour female condom)
|
Device: Medtech female condom
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 |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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 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 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 not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms
- 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
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452503
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)
Reproductive Health and HIV Research Unit (RHRU) in association with the University of the Witwatersrand in Durban, South Africa.
Investigators
| Principal Investigator: | Mags Beksinska, BSc, MSc. PhD | RHRU |
More Information
No publications provided by FHI 360
Additional 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: | October 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
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 February 27, 2015