Functional Performance, Synthetic Male Condom
Conditions
Keywords
functional performance, synthetic male condom
Brief summary
Over the decades, male condoms had been widely commercialized and used to protect against unintended pregnancy and sexually transmitted infections (STI). While natural rubber latex (NRL) male condoms has majority proportion of male condoms in the market, synthetic male condoms (SMC) made from polyurethane or other synthetic materials remain new to the consumers. Notably, synthetic male condoms are found to be more durable, non-allergenic and have better compatibility with lubricants when compared to NRL male condoms. The SMCs that have FDA approval and commercially available are AvantiTM (polyisoprene condom), Trojan SupraTM (polyurethane condom) and eZ.onTM (polyurethane condom). Although the effectiveness of SMCs in the prevention of sexually transmitted infections has yet to be established, SMCs are believed to be comparable to NRL male condoms in both STI prevention and contraception protection. Notwithstanding, a recent literature had reported the shortfall on the quality of variant male condoms in the market, especially nonconforming volumetric capacity, burst pressure and freedom from holes. This warrant the current investigation, to evaluate the functional performances of two newly invented synthetic male condoms, branded as WONDALEAF-CAP (WLC) and WONDALEAF-ON-MAN (WLM). Apart from being made of polyurethane, the major feature of WLC and WLM are nonetheless their adhesive coating on the outer rim of the condom opening which by securely adhering to the foreskin, prevent slippage of condom and spillage of male ejaculate or secretions when the penis is flaccid, and thereby improve the user-friendliness of condom usage.
Interventions
DEVICE(1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)
1. WONDALEAF-ON-MEN (WLM) is a polyurethane pouch with outstretching adhesive shield. The pouch covers the penis in man user; while the adhesive shield covers the groin regions to provide extra protection for the couples. The pouch is equivalent to marketed polyurethane male; while the adhesive shield is equivalent to marketed polyurethane wound dressing. WLM integrally joined with an adhesive wound dressing, both made of the same polyurethane material. 2. WONDALEAF-CAP (WLC) is a miniature form of WLM: the pouch covers glans penis and the adhesive shield wraps around the shaft of the penis only, thereby emulating the configuration of a donned regular condom on the penis. Because of the adhesive coating, WLC overcomes the problems of slippage when the penis is flaccid. 3. The durex-TOGETHER serves as the active comparator in this study. It is a transparent natural rubber latex male condom which is commercially available.
Sponsors
Twin Catalyst Sdn. Bhd.
Sarawak Research Society
Clinical Research Centre, Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)
Masking description
Throughout the study, neither participating couples, clinic staff, research assistants or researchers are masked to condom assignment as there are observable differences on packaging and design between the test condom (WLC and WLM) and the control condom (durex-Together). However, statisticians, sponsors, and medical reviewers are masked until completion of the final report to minimize biases potentially emerge during data analyses and results reporting.
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Their female sexual partners are not at risk of pregnancy (using alternate contraception); 2. They don't have known sexually transmitted infections, including HIV/AIDS; 3. They should be experienced condom users, minimum 10 male condoms used in the last 12 months; 4. They are between 18 to 45 years of age; 5. They are in a monogamous heterosexual relationship and agree to practice vaginal sex only using male condoms provided by the study.
Exclusion criteria
1. couples who work for the research team or who are close relatives of the research team; 2. men with known allergy to natural rubber latex; 3. men with known sensitivity to the residual chemicals used in the manufacture of natural rubber latex condoms or the test condom materials; 4. couples where one knowingly has a sexually transmitted infection. 5. couples who are pregnant in time of recruitment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Slippage Rates (CSR) | Through study completion, an average of 3 months. In specific, CSR will be evaluated within 24 hours after use of individual condom, for each condom type | Number of condoms that slipped completely off the penis during intercourse or withdrawal, divided by the number of condoms used during intercourse; reported as a percentage. |
| Clinical Breakage Rates (CBR) | Through study completion, an average of 3 months. In specific, CBR will be evaluated within 24 hours after use of individual condom, for each condom type | Number of condoms that broke during intercourse or withdrawal, divided by the number of condoms used during intercourse; reported as a percentage. |
| Clinical Failure Rates (CFR) | Through study completion, an average of 3 months. In specific, CFR will be calculated after completion of four times usage, for each condom type | CFR is the sum of CSR and CBR for each condom type |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Favorability of product attributes | Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type | This will reflect the acceptability of the male condoms used. It is a self-reported favorability towards attributes of each male condoms' type used |
| Incidence of Treatment-Emergent Adverse Events | Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type | This outcome will reflect the safety of the male condoms used. Proportion of participants with symptoms of and proportion of condom uses with reports of individual complaints (eg. irritation, burning, itching, bleeding, etc.) during or immediately after any of the 3 separate uses will be calculated for each condom type. Adverse events will be classified by relatedness, expectedness and severity. |
| Adequacy and feel of lubrication | Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type | This will reflect the acceptability of the male condoms used. It is a self-reported adequacy and feel of lubrication for each type of male condoms used. |
| Comfort in use | Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type | This will reflect the acceptability of the male condoms used. It is a self-reported comfortability on each type of male condoms used |
| Ease of insertion and removal | Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type | This will reflect the acceptability of the male condoms used. It is a self-reported ease of insertion and removal for each type of male condoms used |
Countries
Malaysia
Outcome results
None listed