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Contraception. 2019 Jul;100(1):65-71. doi: 10.1016/j.contraception.2019.02.013. Epub 2019 Mar 11.

Pilot study on functional performance and acceptability of two new synthetic adhesive male condoms (Wondaleaf): a randomized cross-over trial.

Author information

1
Sarawak Research Society, Lot 56, Phase 5, Lorong Greenwood 21, Greenwood Park Batu 9 ½ Jalan Kuching-Serian, 94200 Kuching, Sarawak, Malaysia; Institute of Borneo Studies, Universiti Malaysia Sarawak, Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia. Electronic address: tingchuoyew@gmail.com.
2
Monash University Malaysia, Jeffrey Cheah School of Medicine and Health Sciences, Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, Malaysia. Electronic address: ting.singkiat@monash.edu.
3
Clinical Research Center, Sarawak General Hospital, Jalan Hospital, 93586, Kuching, Sarawak, Malaysia. Electronic address: limchienjoo90@gmail.com.
4
Clinical Research Center, Sarawak General Hospital, Jalan Hospital, 93586, Kuching, Sarawak, Malaysia; Pharmacy Department, Sarawak General Hospital, Jalan Hospital, 93586, Kuching, Sarawak, Malaysia. Electronic address: kingtl.crc@gmail.com.
5
Sarawak Research Society, Lot 56, Phase 5, Lorong Greenwood 21, Greenwood Park Batu 9 ½ Jalan Kuching-Serian, 94200 Kuching, Sarawak, Malaysia; Faculty of Hospitality and Tourism Management, UCSI University, Muara Tebas Land District, Sejingkat, 93450 Kuching, Sarawak, Malaysia. Electronic address: hiramparousia@gmail.com.
6
Enersol Pty Ltd, 235 Nelson St, Annandale, NSW, 2038, Australia. Electronic address: jgerofi@enersol.com.au.

Abstract

OBJECTIVES:

This study compared the condom failure rate, safety and acceptability of two new synthetic adhesive male condoms, Wondaleaf-Cap® (WLC) and Wondaleaf-On-Man® (WLM), with a marketed latex external condom Durex®-Together (DT).

STUDY DESIGN:

We enrolled healthy married, monogamous, heterosexual condom users in a randomized controlled, cross-over, pilot trial in Malaysia. We randomized participants to six groups with different condom use-orders of the experimental WLC and WLM and control latex condom for four episodes for vaginal sex over 1 month for each condom type. We summarized the clinical and non-clinical failure rate, safety and acceptability of each condom type using descriptive statistics. We tested differences in condom failure and acceptability using generalized estimating equations and repeated measure ANOVA respectively.

RESULTS:

We screened 75 couples and randomized 50 eligible couples. Two couples withdrew before receiving any condom. The remaining used 576 condoms with 192 uses for each condom variant. Clinical failure rates of WLC, WLM and DT were 1.04%, 0% and 0.52%, respectively. Non-clinical failure rates of WLC, WLM and DT were 2.08%, 3.12% and 1.04%, respectively. Removal was found more painful with Wondaleaf products than the DT. Preferences of participants for WLC, WLM and DT were 33.3%, 29.2% and 25%, respectively. Overall, WLC and DT had greater acceptances among male participants than WLM.

CONCLUSION:

Results of this pilot study support that use of synthetic adhesive male condoms is associated with failure rates similar to those seen with existing latex, and with greater acceptability. A larger study to ascertain non-inferiority is underway.

IMPLICATIONS:

The availability of synthetic adhesive male condoms may increase the acceptability of condom use. However, removal pain and clinical performance requires further study.

KEYWORDS:

Condom failure rate; External condom; Functional performance; Synthetic adhesive male condom; Wondaleaf

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