General objective: To assess the performance and safety profile of a novel innovative design of female condom (Wondaleaf®) among healthy married women. Specific objectives : * To determine the failure rate of Wondaleaf®, in terms of clinical breakage, non-clinical breakage, invagination, misdirection, and slippage. * To determine the acceptability and satisfaction of use of Wondaleaf® by subjects and their spouses. * To assess the safety profile of Wondaleaf®.
This is a single-centre clinical trial to assess the performance and safety profile of Wondaleaf® in healthy married women. Referrals from doctors and nurses in the Maternal and Child Health Clinics, Family Planning Clinics and private clinics in Sibu will be received. A total of 63 couples will be recruited to use Wondaleaf® and to study self-reported total clinical failure and total female condom failure and their components failure events of clinical breakage, non-clinical breakage, total breakage, slippage, misdirection, and invagination (as per World Health Organisation (WHO) Female Condom Technical Review Committee definition(1)). Secondary outcomes were safety parameters (retention of investigational device intra-vaginally should it break, complaint of sexually transmitted diseases, vaginal infection and/or urinary tract infections, all adverse events, serious adverse events, adverse device events and serious adverse device events, allergic reaction) as well as acceptability and satisfaction of the use of Wondaleaf®. A focus group discussion will be held for the first two couples, to a maximum of five couples recruited based on the same inclusion and exclusion criteria will be asked to trial the process of training / counselling of using the condom, as well as completing the coital log. Experience gathered from these focus group testing and discussion, will be used to enhance the strength of this protocol. Subsequently, each couple will be asked to use five Wondaleaf® and to complete a coital log at home after each condom use. Before putting on the investigational device, the subject must check for device or package breakage. During sexual intercourse, the couple ought to notice if any breakage of the condom has occurred, and if the female condom slips completely out of the vagina or the penis of male spouse is inserted between the condom and the vaginal wall as well as event of invagination (when the external retention feature of the female condom is partly or fully pushed into the vagina). Each subject must maintain the wearing of investigational device for the entire process of intercourse until the male spouse ejaculate intra-vaginally. Following each ejaculation of the male spouse, the investigational devices must be checked for breakage before, during and after withdrawal of the condom from the vagina. A coital log must be completed by the couples within 12 hours after the use of each investigational device. Coital logs are used to obtain data for condom performance and safety. The five female investigational devices should be used within a period of four weeks. The used investigational devices shall be discarded safely in the usual and safe manner at home. After the women completed five uses of Wondaleaf® or after four weeks (whichever occurs first), they will return to the clinic to return their coital log and to fill out an acceptability and satisfaction questionnaire. Any unused female investigational devices (i.e. the female condom) will be returned for counting purposes. If the women were confirmed pregnant during study period, the subjects will be withdrawn from the study. The married couple will be referred for antenatal care of their choice.
Use of Wondaleaf® during sexual intercourse with husband for 5 times in a month period
Sibu Hospital
Sibu, Sarawak, Malaysia
Total female condom failure
Number of times a non-clinical breakage, clinical breakage, or slippage occurs, or that is associated with misdirection, invagination, or any additional failure modes identified in the risk assessment
Time frame: Five uses of investigational devices, an average of one month
Total clinical failure
the numbers of female condoms that clinically break or slip, or that are associated with misdirection, invagination, or any additional failure modes identified in the risk assessment, which result in reduction of the protective function of the condom.
Time frame: Five uses of investigational devices, an average of one month
Clinical breakage
The number of times a breakage of the condom during sexual intercourse or during withdrawal of the female condom from the vagina (potential adverse clinical consequences) occurs
Time frame: Five uses of investigational devices, an average of one month
Non-clinical breakage
Number of times a breakage is noticed before intercourse or occurring after withdrawal of the condom from the vagina (no potential adverse clinical consequences)
Time frame: Five uses of investigational devices, an average of one month
Total breakage
the number of all condom breakages at any time before, during, or after sexual intercourse; includes both clinical and non-clinical breakages
Time frame: Five uses of investigational devices, an average of one month
Slippage
Number of times when a female condom slips completely out of the vagina during sexual intercourse
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
21
Time frame: Five uses of investigational devices, an average of one month
Misdirection
Number of times a vaginal penetration whereby the penis is inserted between the condom and the vaginal wall occurs
Time frame: Five uses of investigational devices, an average of one month
Invagination
Number of times when the external retention feature of the female condom is partly or fully pushed into the vagina during sexual intercourse
Time frame: Five uses of investigational devices, an average of one month
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Monitoring of adverse event (locally at the perineum and/or vagina, per vaginal discharge, or any systemic reaction; and local reaction of the penis of the spouse) and adverse device event, as well as if Wondaleaf® ever breaks, if any portion of it retain intra-vaginally
Time frame: Five uses of investigational device, an average of one month
Satisfaction
Satisfaction as assessed by the Satisfaction Questionnaire (Beksinska et al, 2013) - which assess using Likert scale ease of condom use/remove, comfort during sex, satisfaction with feeling of sex, in comparison to male condom and no condom, and preference with regards to male condom
Time frame: Five uses of investigational device, an average of one month
Acceptability
Acceptability as assessed by four study-designed questions about Wondaleaf on whether Wondaleaf is a useful device for use worldwide and in Malaysia (very useful, moderately useful, not useful); if it is generally acceptable as female condom worldwide and in Malaysia (very acceptable, acceptable, unsure, not acceptable, highly unacceptable).
Time frame: Five uses of investigational device, an average of one month