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

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ClinicalTrials.gov Identifier: NCT03324594
Recruitment Status : Completed
First Posted : October 27, 2017
Last Update Posted : July 18, 2018
Sponsor:
Collaborators:
Twin Catalyst Sdn. Bhd.
Sarawak Research Society
Information provided by (Responsible Party):
Clinical Research Centre, Malaysia

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.

Condition or disease Intervention/treatment Phase
Functional Performance Synthetic Male Condom Device: (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Primary Purpose: Device Feasibility
Official Title: A Pilot Functional Performances Study of The Wondaleaf-Cap and The Wondaleaf-On-Man Synthetic Male Condom
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Arm Intervention/treatment
Active Comparator: Group A
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.
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.

Active Comparator: Group B
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.
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.

Active Comparator: Group C
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.
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.

Active Comparator: Group D
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.
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.

Active Comparator: Group E
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.
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.

Active Comparator: Group F
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.
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.




Primary Outcome Measures :
  1. Clinical Slippage Rates (CSR) [ Time Frame: 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.

  2. Clinical Breakage Rates (CBR) [ Time Frame: 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.

  3. Clinical Failure Rates (CFR) [ Time Frame: 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 Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 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.

  2. Comfort in use [ Time Frame: 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

  3. Ease of insertion and removal [ Time Frame: 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

  4. Favorability of product attributes [ Time Frame: 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

  5. Adequacy and feel of lubrication [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324594


Locations
Malaysia
Sarawak Family Planning Association
Kuching, Sarawak, Malaysia, 93400
Sarawak Research Society
Kuching, Sarawak, Malaysia, 94200
Sponsors and Collaborators
Clinical Research Centre, Malaysia
Twin Catalyst Sdn. Bhd.
Sarawak Research Society
Investigators
Principal Investigator: Chuo Yew Ting, BPharm., MPhil. (1) Sarawak Research Society, (2) Sarawak State Health Department, Ministry of Health

Additional Information:
Publications:
Responsible Party: Clinical Research Centre, Malaysia
ClinicalTrials.gov Identifier: NCT03324594     History of Changes
Other Study ID Numbers: NMRR-17-1895-37590
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clinical Research Centre, Malaysia:
functional performance
synthetic male condom