Wondaleaf Unisex Condom
- User: Female/Male
- Hormonal: Non-Hormonal
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Delivery type:
- Barrier
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Intended Duration:
- Pericoital
- Development Stage: Single-Country Approval
- Developer(s)/researcher(s): MRU - University of Witwatersrand, Twin Catalyst Sdn Bhd
Details
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Mechanism of Action:
- Physical Barrier
- Inactive Materials: Rubber Latex
- Regimen: On Demand
- MPT: Potential MPT
- Promising Attributes: The unisex condom was found in a single-center RCT to be superior to a reference product in invagination, misdirection, and clinical failure. It can be used internally and externally, broadening its potential user base.
Product Status
Single-Country Approval: Malaysia
History
The Wondaleaf unisex condom was developed to be used either externally or internally. In 2023, the condom was determined to be non-inferior (and for some indicators, superior) to the FC2, an internal condom with active WHO PQ. Wondaleaf has publicly announced their intent to pursue WHO PQ. In 2024, Wondaleaf received Medical Device Authorization from the Malaysia Medical Device Authority, a 5-year marketing approval which allows for the distribution of Wondaleaf in Malaysia.