- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01452503
Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6
September 11, 2023 updated by: FHI 360
Evaluation of preference for three female condoms (FC).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Durban, South Africa, 4001
- Commercial City Clinic Department of Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PATH Women's Condom
|
comparison between 3 types of female condoms
|
Active Comparator: FC2 female condom
Female Health Company's FC2 female condom
|
comparison between 3 types of female condoms
|
Active Comparator: Reddy 6 female condom (V-Amour)
Reddy 6 female condom (Commercially known as the V-Amour female condom)
|
comparison between 3 types of female condoms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of each of the female condom types
Time Frame: 3 months
|
safety measured by number of particpants with adverse events
|
3 months
|
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
|
3 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mags Beksinska, MSc. PhD, RHRU
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
August 19, 2011
First Submitted That Met QC Criteria
October 14, 2011
First Posted (Estimated)
October 17, 2011
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
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
- 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
- ICH International Conference of Harmonization
Other Study ID Numbers
- 9928
- USAID (Other Grant/Funding Number: GPO-A-00-05-00022-00;(W0118))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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