Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6
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| ClinicalTrials.gov Identifier: NCT01452503 |
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Recruitment Status :
Completed
First Posted : October 17, 2011
Last Update Posted : May 25, 2016
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Sponsor:
FHI 360
Collaborators:
United States Agency for International Development (USAID)
University of Witwatersrand, South Africa
Information provided by (Responsible Party):
FHI 360
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Brief Summary:
Evaluation of preference for three female condoms (FC).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Contraception | Device: Path Women's Condom Device: FC2 female condom Device: Reddy 6 female condom (V-Amour) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 170 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Official Title: | Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6 |
| Study Start Date : | May 2007 |
| Actual Primary Completion Date : | February 2008 |
| Actual Study Completion Date : | April 2008 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: PATH Women's Condom
PATH Women's Condom
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Device: Path Women's Condom
comparison between 3 types of female condoms |
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Active Comparator: FC2 female condom
Female Health Company's FC2 female condom
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Device: FC2 female condom
comparison between 3 types of female condoms |
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Active Comparator: Reddy 6 female condom (V-Amour)
Reddy 6 female condom (Commercially known as the V-Amour female condom)
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Device: Reddy 6 female condom (V-Amour)
comparison between 3 types of female condoms |
Primary Outcome Measures :
- Preference of female condom by type [ Time Frame: 3 months ]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 ]safety measured by number of particpants with adverse events
- Function of each of the female condom types [ Time Frame: 3 Months ]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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
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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.
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
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 ( Other Grant/Funding Number: GPO-A-00-05-00022-00;(W0118) ) |
| First Posted: | October 17, 2011 Key Record Dates |
| Last Update Posted: | May 25, 2016 |
| Last Verified: | May 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by FHI 360:
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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 |