Ignite Creation Date:
2024-05-06 @ 1:36 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04076774
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2019-08-28
Brief Title:
A Functional Performance Study of The Wondaleaf Female Condom
Sponsor:
Prof Mags Beksinska
Organization:
University of Witwatersrand South Africa
Study Overview
Official Title:
A Functional Performance Study of The Wondaleaf Female Condom
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study will determine how well two female condoms perform when used during sex One of these condoms FC2 is already commercially available in South Africa The other female condom Wondaleaf Condom is a new female condom Participants will use both condoms The study aims to determine how well these condoms work comparatively Study visits include a screeningenrolment visit and 2 follow up visits
Detailed Description:
This research study will determine how well two female condoms perform when used during sex One of these condoms FC2 is already commercially available in South Africa The other female condom Wondaleaf Condom is a new female condom Participants will use both condoms The study aims to determine how well these condoms work comparatively
The Wondaleaf female condom is a new female condom FC design made of polyurethane with no external or internal rings The body of the condom is fitted by an exterior adhesive shield which also displays the condom when removed from the condom packaging
Purpose To ascertain the functional performance of the Wondaleaf FC This research study will be a two-period cross-over randomized controlled trial to compare the functional performance safety and acceptability of two FC types
Study Design The study will enrol 220 women anticipating that 200 participants complete the study The age range of these participants is from 18-45 years Each participant will be asked to use five Wondaleaf FCs and five FC2 female condoms available in the South African public sector
Primary endpoints will be total clinical failure and total device failure for each condom type Secondary endpoints will include rates of invagination complete slippage misdirection and breakage
Function safety and acceptability will be assessed at two follow-up visits approximately one month apart after enrollment Participants will complete a Condom Log at home which gathers data on experience after use of each condom
Female clients of the Commercial City Clinic will be told about the study If a potential participant expresses interest in participating the participant will be given the study information to read which will describe the study requirements and the potential role in the study If the participant agrees to take part in the research the participant will be asked to provide written consent The participant will be screened to ensure that the requirements for study participation are met
Enrolled participants will be asked to use five FC2 and five Wondaleaf FCs Participants will be asked to return to the clinic for follow-up after using each type of device During the 1st follow-up visit participants will be interviewed about the first assigned condom type and will receive the next condom packet within their second assigned randomized use sequence In the second follow-up visit participants will be interviewed about use of the condoms and will be discontinued from study participation Data on device function safety and acceptability for each condom type will be collected during follow-up visits
At enrolment baseline data will be gathered on participant demographics and past FC use via the baseline questionnaire Using a pelvic model the study staff will demonstrate female condom insertion and train the participants in the proper use of the first assigned female condom Further study staff will re- emphasize the instructions on how to complete the condom use log Participants will be told that they do not have to use the FCs during consecutive acts of intercourse The study staff will discuss with the participant an approximate timeframe for use of all 5 condoms and a suitable follow-up date will be scheduled This date will be noted on an appointment slip Participants will be encouraged to come back if condoms are finished before the due date and will be given the research study contact details to call for any appointment changes
Follow-up visits There will be two follow-up visits During the first follow-up visit study staff will review the information on the Condom Use Logs for completeness and accuracy Further the participants will be asked questions from a follow-up survey about the experiences using the FCs Participants will be trained in the use of the second condom type and given appropriate written condom use instructions Staff will schedule the second follow-up visit and participants will obtain the next condom packet in the assigned use sequence At the end of the second follow-up visit the discontinuation form will be completed Participation period for study participants is expected to last between 2-4 months
The study will be registered on the South African clinical trials registry SANCTR and on clinicaltrialsgov
The study will be monitored by an independent monitor contracted by the study investigator The monitoring visit schedule includes an initiation visit one interim visit and a close out visit Risk based monitoring will be conducted for the study The following study records will be reviewed
100 of informed consent forms
100 of 100 enrolled participant files for source data verification
100 of serious adverse events and protocol deviations
Investigator site file
Study product No audits are planned for the study The study has employed data staff to complete daily quality control of documents to ensure accuracy and completeness of data and electronic case report forms
The site has Standard Operating Procedures in place to ensure consistency of site operations and study procedures In addition a source document guide and Manual of Procedures will be developed to ensure conformity
Statistical Considerations
The hypothesis for the primary endpoints total clinical failure and total failure of a female condom and their components is that the new condom WC2 is non-inferior to FC2 with regard to the rate of events within a margin of 30 That is that the rate of events of each of the new condoms is not worse than that of the FC2 by more than 30
To demonstrate non-inferiority at a 5 significance level the study will require the upper limit of the one-sided 95 confidence interval or equivalently the upper limit of the two-sided 90 confidence interval for the difference in the occurrence of events New - FC2 to be below 30
It was calculated that the power to demonstrate non-inferiority obtained for different sample sizes starting by the minimum of 200 couples completing the study recommended by ISO standards It was assumed a total failure rate of 4 for the FC2 as reported from past research It was assumed a correlation between uses of 015 as reported for male condoms This assumption is more conservative than the maximum of 020 recommended by International Organization for Standardization ISO standards for female condoms
For acceptability scores ranging from 1 lowest to 5 highest to be compared across condom types using Friedman test the proposed sample size will provide more than 99 power to detect a minimum difference of 1 in the scores of any two condom types in a 5 significance level two-sided test This calculation assumes a standard error of 1 and adjusts for multiple inferences using Bonferroni criterion but ignores clustering condoms within couples
Data Analysis All analyses for primary and secondary endpoints will be performed according to the assigned condom use sequence among the subset of participants who provide relevant follow-up data on at least one condom of each type no matter if they followed the assigned sequence This will be the main analysis An additional analysis will be performed with protocol compliers ie participants who follow the assigned condom use sequence All analyses for secondary endpoints will use a nominal 5 significance level
A detailed analysis plan will be developed prior to the initiation of study enrollment Any deviations to be made from this summary will be documented in the detailed analysis plan
Condom Function The failure rates or proportions of condom uses with clinical breakage total breakage slippage misdirection invagination total clinical failure and total FC failure will be summarized by condom type according to endpoint definitions 95 confidence intervals for the proportion of each endpoint will be calculated using the exact method based on the binomial distribution
Safety Data The proportion of participants with symptoms of genitourinary irritation during or immediately after any of the 5 separate uses and medical and serious adverse events classified by relatedness to condom type expectedness and severity will be reported
Product Acceptability The key acceptability endpoints listed below will be summarized
comfort in use
ease of insertion and removal
like or dislike of product attributes and adequacy and feel of lubrication
The Wondaleaf female condom is a new female condom FC design made of polyurethane with no external or internal rings The body of the condom is fitted by an exterior adhesive shield which also displays the condom when removed from the condom packaging
Purpose To ascertain the functional performance of the Wondaleaf FC This research study will be a two-period cross-over randomized controlled trial to compare the functional performance safety and acceptability of two FC types
Study Design The study will enrol 220 women anticipating that 200 participants complete the study The age range of these participants is from 18-45 years Each participant will be asked to use five Wondaleaf FCs and five FC2 female condoms available in the South African public sector
Primary endpoints will be total clinical failure and total device failure for each condom type Secondary endpoints will include rates of invagination complete slippage misdirection and breakage
Function safety and acceptability will be assessed at two follow-up visits approximately one month apart after enrollment Participants will complete a Condom Log at home which gathers data on experience after use of each condom
Female clients of the Commercial City Clinic will be told about the study If a potential participant expresses interest in participating the participant will be given the study information to read which will describe the study requirements and the potential role in the study If the participant agrees to take part in the research the participant will be asked to provide written consent The participant will be screened to ensure that the requirements for study participation are met
Enrolled participants will be asked to use five FC2 and five Wondaleaf FCs Participants will be asked to return to the clinic for follow-up after using each type of device During the 1st follow-up visit participants will be interviewed about the first assigned condom type and will receive the next condom packet within their second assigned randomized use sequence In the second follow-up visit participants will be interviewed about use of the condoms and will be discontinued from study participation Data on device function safety and acceptability for each condom type will be collected during follow-up visits
At enrolment baseline data will be gathered on participant demographics and past FC use via the baseline questionnaire Using a pelvic model the study staff will demonstrate female condom insertion and train the participants in the proper use of the first assigned female condom Further study staff will re- emphasize the instructions on how to complete the condom use log Participants will be told that they do not have to use the FCs during consecutive acts of intercourse The study staff will discuss with the participant an approximate timeframe for use of all 5 condoms and a suitable follow-up date will be scheduled This date will be noted on an appointment slip Participants will be encouraged to come back if condoms are finished before the due date and will be given the research study contact details to call for any appointment changes
Follow-up visits There will be two follow-up visits During the first follow-up visit study staff will review the information on the Condom Use Logs for completeness and accuracy Further the participants will be asked questions from a follow-up survey about the experiences using the FCs Participants will be trained in the use of the second condom type and given appropriate written condom use instructions Staff will schedule the second follow-up visit and participants will obtain the next condom packet in the assigned use sequence At the end of the second follow-up visit the discontinuation form will be completed Participation period for study participants is expected to last between 2-4 months
The study will be registered on the South African clinical trials registry SANCTR and on clinicaltrialsgov
The study will be monitored by an independent monitor contracted by the study investigator The monitoring visit schedule includes an initiation visit one interim visit and a close out visit Risk based monitoring will be conducted for the study The following study records will be reviewed
100 of informed consent forms
100 of 100 enrolled participant files for source data verification
100 of serious adverse events and protocol deviations
Investigator site file
Study product No audits are planned for the study The study has employed data staff to complete daily quality control of documents to ensure accuracy and completeness of data and electronic case report forms
The site has Standard Operating Procedures in place to ensure consistency of site operations and study procedures In addition a source document guide and Manual of Procedures will be developed to ensure conformity
Statistical Considerations
The hypothesis for the primary endpoints total clinical failure and total failure of a female condom and their components is that the new condom WC2 is non-inferior to FC2 with regard to the rate of events within a margin of 30 That is that the rate of events of each of the new condoms is not worse than that of the FC2 by more than 30
To demonstrate non-inferiority at a 5 significance level the study will require the upper limit of the one-sided 95 confidence interval or equivalently the upper limit of the two-sided 90 confidence interval for the difference in the occurrence of events New - FC2 to be below 30
It was calculated that the power to demonstrate non-inferiority obtained for different sample sizes starting by the minimum of 200 couples completing the study recommended by ISO standards It was assumed a total failure rate of 4 for the FC2 as reported from past research It was assumed a correlation between uses of 015 as reported for male condoms This assumption is more conservative than the maximum of 020 recommended by International Organization for Standardization ISO standards for female condoms
For acceptability scores ranging from 1 lowest to 5 highest to be compared across condom types using Friedman test the proposed sample size will provide more than 99 power to detect a minimum difference of 1 in the scores of any two condom types in a 5 significance level two-sided test This calculation assumes a standard error of 1 and adjusts for multiple inferences using Bonferroni criterion but ignores clustering condoms within couples
Data Analysis All analyses for primary and secondary endpoints will be performed according to the assigned condom use sequence among the subset of participants who provide relevant follow-up data on at least one condom of each type no matter if they followed the assigned sequence This will be the main analysis An additional analysis will be performed with protocol compliers ie participants who follow the assigned condom use sequence All analyses for secondary endpoints will use a nominal 5 significance level
A detailed analysis plan will be developed prior to the initiation of study enrollment Any deviations to be made from this summary will be documented in the detailed analysis plan
Condom Function The failure rates or proportions of condom uses with clinical breakage total breakage slippage misdirection invagination total clinical failure and total FC failure will be summarized by condom type according to endpoint definitions 95 confidence intervals for the proportion of each endpoint will be calculated using the exact method based on the binomial distribution
Safety Data The proportion of participants with symptoms of genitourinary irritation during or immediately after any of the 5 separate uses and medical and serious adverse events classified by relatedness to condom type expectedness and severity will be reported
Product Acceptability The key acceptability endpoints listed below will be summarized
comfort in use
ease of insertion and removal
like or dislike of product attributes and adequacy and feel of lubrication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5020 | REGISTRY | South African Clinical Trials Registry | None |