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| Name | Class |
|---|---|
| Twin Catalyst Sdn. Bhd. | INDUSTRY |
| Sarawak Research Society | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Participants will be first given (1) WONDALEAF-CAP, followed by (2) WONDALEAF-ON-MEN, and last with (3) durex-TOGETHER after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type. |
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| Group B | Active Comparator | Participants will be first given (1) WONDALEAF-CAP, followed by (2) durex-TOGETHER, and last with (3) WONDALEAF-ON-MEN after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type. |
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| Group C | Active Comparator | Participants will be first given (1) WONDALEAF-ON-MEN, followed by (2) durex-TOGETHER, and last with (3) WONDALEAF-CAP after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type. |
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| Group D |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator) | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Slippage Rates (CSR) | 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. | 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 |
| Clinical Breakage Rates (CBR) | Number of condoms that broke during intercourse or withdrawal, divided by the number of condoms used during intercourse; reported as a percentage. | 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 |
| Clinical Failure Rates (CFR) | CFR is the sum of CSR and CBR for each condom type | Through study completion, an average of 3 months. In specific, CFR will be calculated after completion of four times usage, for each condom type |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Due to the nature of the studied intervention (male condom), only male respondents who fulfill the inclusion and exclusion criteria will be eligible for participation.
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| Name | Affiliation | Role |
|---|---|---|
| Chuo Yew Ting, BPharm., MPhil. | (1) Sarawak Research Society, (2) Sarawak State Health Department, Ministry of Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarawak Family Planning Association | Kuching | Sarawak | 93400 | Malaysia | ||
| Sarawak Research Society |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12201325 | Background | Bounds W, Molloy S, Guillebaud J. Pilot study of short-term acceptability and breakage and slippage rates for the loose-fitting polyurethane male condom eZ.on bi-directional: a randomized cross-over trial. Eur J Contracept Reprod Health Care. 2002 Jun;7(2):71-8. | |
| 27923380 | Background | Duarte JT, de Almeida AE, de Mello Pereira Abrantes S. Quality evaluation of commercially available male condoms in Rio de Janeiro, Brazil, 2009-2011. Reprod Health. 2016 Dec 7;13(1):145. doi: 10.1186/s12978-016-0254-5. |
| Label | URL |
|---|---|
| ISO/WD 29943-1. Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self-reports | View source |
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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.
| Active Comparator |
Participants will be first given (1) WONDALEAF-ON-MEN, followed by (2) WONDALEAF-CAP, and last with (3) durex-TOGETHER after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type. |
|
| Group E | Active Comparator | Participants will be first given (1) durex-TOGETHER, followed by (2) WONDALEAF-ON-MEN, and last with (3) WONDALEAF-CAP after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type. |
|
| Group F | Active Comparator | Participants will be first given (1) durex-TOGETHER, followed by (2) WONDALEAF-CAP, and last with (3) WONDALEAF-ON-MEN after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type. |
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| Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type |
| Comfort in use | This will reflect the acceptability of the male condoms used. It is a self-reported comfortability on each type of male condoms used | Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type |
| Ease of insertion and removal | 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 | Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type |
| Favorability of product attributes | This will reflect the acceptability of the male condoms used. It is a self-reported favorability towards attributes of each male condoms' type used | Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type |
| Adequacy and feel of lubrication | 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. | Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type |
| Kuching |
| Sarawak |
| 94200 |
| Malaysia |
| 9792386 | Background | Fontanet AL, Saba J, Chandelying V, Sakondhavat C, Bhiraleus P, Rugpao S, Chongsomchai C, Kiriwat O, Tovanabutra S, Dally L, Lange JM, Rojanapithayakorn W. Protection against sexually transmitted diseases by granting sex workers in Thailand the choice of using the male or female condom: results from a randomized controlled trial. AIDS. 1998 Oct 1;12(14):1851-9. doi: 10.1097/00002030-199814000-00017. |
| 12916135 | Background | French PP, Latka M, Gollub EL, Rogers C, Hoover DR, Stein ZA. Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sex Transm Dis. 2003 May;30(5):433-9. doi: 10.1097/00007435-200305000-00010. |
| 16437459 | Background | Gallo MF, Grimes DA, Lopez LM, Schulz KF. Non-latex versus latex male condoms for contraception. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD003550. doi: 10.1002/14651858.CD003550.pub2. |
| 30871936 | Derived | Ting CY, Ting RS, Lim CJ, King TL, Ting H, Gerofi J. Pilot study on functional performance and acceptability of two new synthetic adhesive male condoms (Wondaleaf): a randomized cross-over trial. Contraception. 2019 Jul;100(1):65-71. doi: 10.1016/j.contraception.2019.02.013. Epub 2019 Mar 11. |