235
Participants
Start Date
May 31, 2025
Primary Completion Date
May 31, 2026
Study Completion Date
May 31, 2026
Miss Liberty Condom
The Miss Liberty female condom is manufactured by Zhejiang Rui Bo 001 High Polymer Co, Ltd. The condom is designed as a loose-fitting pouch that lines the vagina. It has two flexible rings. The sheath, are made of polyurethane. The outer ring remains outside the vagina and covers the external genitalia during intercourse. An internal ring is removable and serves as the insertion mechanism and anchors the device within the vagina. Miss Liberty measures 180mm in length and 78mm in lay-flat width. The device is pre-lubricated with silicone oil. This condom is a similar design (material, length, width) to the USFDA approved FC1 female condom which was discontinued and replaced by FC2.
FC2 condom
The FC2 is a second-generation female condom manufactured by the Female Health Company (Chicago, IL). The FC2 has US FDA approval and has been granted the CE Mark of the European Union. The FC2 is pre-qualified by the WHO. The condom is designed as a loose-fitting pouch that lines the vagina. It has two flexible rings. The outer ring at the open end is rolled from the nitrile material. The outer ring remains outside the vagina and covers the external genitalia during intercourse. An internal ring is removable and serves as the insertion mechanism and anchors the device within the vagina. FC2 measures 170mm in length and 80mm in lay-flat width. The device is pre-lubricated with silicone oil. This FC is available in the public health sector in South Africa.
MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit], Durban
University of Witwatersrand, South Africa
OTHER