Background: New female condoms (FCs) are in development that have innovative designs to introduce the FC into the vagina. One of these new designs is the “Wondaleaf” female condom, which has an adhesive shield replacing the outer ring/frame of a typical FC. As the shield covers both internal and external genitalia, it aims to provide better protection against unintended pregnancies and sexually transmitted infections. The primary objective of this research was to compare the functional performance of two FC types- the Wondaleaf FC and FC2, where the FC2 served as the control device.
Methods: This was a two-period, cross-over randomized controlled trial to determine the functional performance, safety and acceptability of Wondaleaf FC and FC2. This study enrolled 55 women in Durban, South Africa in 2017. Primary analyses centered on total clinical failure and total female condom failure. Rates of clinical breakage, total breakage, slippage, misdirection, and invagination were also calculated.
Results: Fifty three of the 55 women enrolled (96%) completed both study follow-up visits. Participants were of a mean age of 28 years with 10 years or more of schooling. All participants had ever used male condoms, and 45.4% had ever used FCs. Total clinical failure was 5.3% for the Wondaleaf FC and 7.5% for FC2. A small number of women had difficulties applying the Wondaleaf shield however once fitted, the shield of the Wondaleaf FC remained adherent in all uses. In three cases some of the shield material was pushed into the vagina, however this did not present an exposure risk. Acceptability was generally higher for the Wondaleaf compared to the FC2. Two-thirds of women (69.8%), and over a half of men (58.4%) stated a preference for Wondaleaf over FC2.
Conclusions: This new design performed well compared to FC2 with lower condom clinical failure and higher acceptability and preference. The design is more complex than a typical FC and requires good instruction for users to fit the adhesive shield.