Woman's Condom
- User: Female
- Hormonal: Non-Hormonal
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Delivery type:
- Barrier
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Intended Duration:
- Pericoital
- Development Stage: Phase III
- Developer(s)/researcher(s): PATH, NICHD, SIPPR (SIBPT), University of Witwatersrand
Details
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Mechanism of Action:
- Physical Barrier
- MPT: Potential MPT
- Promising Attributes: The Woman's Condom (WC) is an internal condom intended to be more comfortable, easier to use, and highly acceptable than other internal condom options
Product Status
Developer Confirms Active Intent to Pursue Regulatory Approval
History
2006: PATH publishes results of a short-term acceptability study of a novel internal condom, the Woman's Condom, at three sites in South Africa, Mexico, and Thailand, finding that the method was easy to use, stable, and comfortable.
2008: A comparative crossover study with the Woman's Condom and the Female Condom 1 (then the only marketed internal condom) finds clinical failure rates of 17% for the Woman's Condom and 24% for the FC1, with users reporting less urogenital irritation with the Woman's Condom and user preference for the novel method over the FC1.
2011: User preference research on internal condoms conducted by FHI 360 in South Africa finds a preference for the second generation internal condom, FC2, and the Woman's Condom are preferred over the V-Amour internal condom, with the Woman's Condom moderately preferred over the FC2 in some parameters.
2011: A Phase III open label, non-comparative trial on the Woman's Condom evaluating safety and efficacy, led by NICHD, initiates with 511 participants at 10 sites in the United States.
2013: The University of Witwatersrand conducts a randomized, controlled non-inferiority crossover trial on the Woman's Condom, the Cupid internal condom, and the VA "worn-of-women" internal condom in comparison to the marketed FC2 in South Africa, showing non-inferiority to FC2 on condom failure events.
2015: US-based Phase III multi-center trial concludes.
2016: SIPPR (Shanghai, China) publishes results of acceptability research among married couples in China, finding high user satisfaction, with 78% of women indicating interest in using the Woman's Condom in the future.
2020: First published results of the Phase III multi-center trial, focused on acceptability, published by NICHD.