Clinical trial NCT03324594: A Pilot Functional Performances Study of Two Synthetic Male Condom
Official title: A Pilot Functional Performances Study of The Wondaleaf-Cap and The Wondaleaf-On-Man Synthetic Male Condom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Performance
Synthetic Male Condom
Keywords: functional performance
synthetic male condom
Lead sponsor: Clinical Research Centre, Malaysia
Sponsor class: OTHER
Collaborators: name: Twin Catalyst Sdn. Bhd.
name: Sarawak Research Society
First posted: 2017-10-27
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility 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

Primary outcomes:
measure: Clinical Slippage Rates (CSR)
timeFrame: 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
measure: Clinical Breakage Rates (CBR)
timeFrame: 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
measure: Clinical Failure Rates (CFR)
timeFrame: Through study completion, an average of 3 months. In specific, CFR will be calculated after completion of four times usage, for each condom type
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
measure: Comfort in use
timeFrame: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
measure: Ease of insertion and removal
timeFrame: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
measure: Favorability of product attributes
timeFrame: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
measure: Adequacy and feel of lubrication
timeFrame: Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
Other outcomes:
Locations:
city: Kuching
country: Malaysia
facility: Sarawak Family Planning Association
state: Sarawak
city: Kuching
country: Malaysia
facility: Sarawak Research Society
state: Sarawak
Study officials:
affiliation: (1) Sarawak Research Society, (2) Sarawak State Health Department, Ministry of Health
name: Chuo Yew Ting, BPharm., MPhil.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.