ContraceptionNCT01452503
Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6
A study testing Path Women's Condom, FC2 female condom and Reddy 6 female condom (V-Amour) in people with Contraception, run by FHI 360 at 1 site in South Africa.
Trial summary
Evaluation of preference for three female condoms (FC). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Path Women's Condom, FC2 female condom and Reddy 6 female condom (V-Amour)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSouth Africa
- Study dates
- May 2007to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Commercial City Clinic Department of Health
Durban, 4001
About this study
Evaluation of preference for three female condoms (FC).
Read the 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.
- Conditions
- Contraception
- Being tested
- Path Women's Condom, FC2 female condom, Reddy 6 female condom (V-Amour)
- 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, 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
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Path Women's CondomDevice
comparison between 3 types of female condoms
FC2 female condomDevice
comparison between 3 types of female condoms
Reddy 6 female condom (V-Amour)Device
comparison between 3 types of female condoms
| Study group | Role | What they receive |
|---|---|---|
| PATH Women's Condom | Active comparator | PATH Women's Condom Receives: Device: Path Women's Condom |
| FC2 female condom | Active comparator | Female Health Company's FC2 female condom Receives: Device: FC2 female condom |
| Reddy 6 female condom (V-Amour) | Active comparator | Reddy 6 female condom (Commercially known as the V-Amour female condom) Receives: Device: Reddy 6 female condom (V-Amour) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
Safety of each of the female condom types
safety measured by number of particpants with adverse events
Measured: 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
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startMay 2007
- Primary completionFeb 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), University of Witwatersrand, South Africa
- Responsible party
- Sponsor
- Investigators
- Mags Beksinska, MSc. PhD, Principal investigator, RHRU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452503
- Sponsor's protocol ID
- 9928
- Other IDs
- USAID
- Status last verified
- Sep 2023
- First submitted
- 19 Aug 2011
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Beksinska M, Smit J, Joanis C, Hart C. Practice makes perfect: reduction in female condom failures and user problems with short-term experience in a randomized trial. Contraception. 2012 Aug;86(2):127-31. doi: 10.1016/j.contraception.2011.11.071. Epub 2012 Jan 20.
PubMed 22264667
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6
- ClinicalTrials.gov ID
- NCT01452503
- Acronym / sponsor ID
- 9928
- Conditions
- Contraception
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), University of Witwatersrand, South Africa
- Study start
- May 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 17 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of preference for three female condoms (FC).
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PATH Women's Condom | Active comparator | Device: Path Women's CondomPATH Women's Condom |
| FC2 female condom | Active comparator | Device: FC2 female condomFemale Health Company's FC2 female condom |
| Reddy 6 female condom (V-Amour) | Active comparator | Device: Reddy 6 female condom (V-Amour)Reddy 6 female condom (Commercially known as the V-Amour female condom) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- All women enrolled in this research must meet the following selection criteria:
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Path Women's Condomcomparison between 3 types of female condoms | Device | PATH Women's Condom |
| FC2 female condomcomparison between 3 types of female condoms | Device | FC2 female condom |
| Reddy 6 female condom (V-Amour)comparison between 3 types of female condoms | Device | Reddy 6 female condom (V-Amour) |
Primary outcome
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.
2 secondary outcomes
Safety of each of the female condom types
Time frame: 3 months
Function of each of the female condom types
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 22264667Beksinska M, Smit J, Joanis C, Hart C. Practice makes perfect: reduction in female condom failures and user problems with short-term experience in a randomized trial. Contraception. 2012 Aug;86(2):127-31. doi: 10.1016/j.contraception.2011.11.071. Epub 2012 Jan 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mags Beksinska, MSc. PhD principal investigator
RHRU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Path Women's Condom, FC2 female condom and Reddy 6 female condom (V-Amour) in people with Contraception, run by FHI 360 at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference of female condom by type (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01452503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.