A Pilot Functional Performances Study of Two Synthetic Male Condom (WONDALEAF-MEN)

Clinical Research Centre, Malaysia

Status: Completed

Conditions: Synthetic Male Condom; Functional Performance

Treatments: Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03324594

NMRR-17-1895-37590

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 6 patient groups

Group A

Active Comparator group

Description:

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.

Treatment:

Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)

Group B

Active Comparator group

Description:

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.

Treatment:

Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)

Group C

Active Comparator group

Description:

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.

Treatment:

Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)

Group D

Active Comparator group

Description:

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.

Treatment:

Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)

Group E

Active Comparator group

Description:

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.

Treatment:

Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)

Group F

Active Comparator group

Description:

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.

Treatment:

Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)