Study: NCT04076774

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Wondaleaf Female Condom
Description: Wondaleaf: Wondaleaf is an ultra thin (of 0.02 mm) polyurethane female/male condom (16x8cm) that has folded extended adhesive shields (front 18x18cm, back 18x10cm), which at unfolding covers the entire external genitalia to prevent direct skin contact and exchange of body fluid between sexual partners during intercourse. Insertion of the condom body into the vagina is through use of a small medical grade cotton tissue packed inside the foil package. This is inserted into the end of the condom body and used to push the condom into the vagina. Each condom is individually packaged without prior lubrication. However, lubricant is expected to be used at donning the condom and during sexual intercourse. The lubricant will be supplied in separate packets together with the condom. Unlike latex, polyurethane condoms are unlikely to cause any allergic reaction and are much stronger than conventional latex condoms

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Wondaleaf Female Condom
Description: Wondaleaf: Wondaleaf is an ultra thin (of 0.02 mm) polyurethane female/male condom (16x8cm) that has folded extended adhesive shields (front 18x18cm, back 18x10cm), which at unfolding covers the entire external genitalia to prevent direct skin contact and exchange of body fluid between sexual partners during intercourse. Insertion of the condom body into the vagina is through use of a small medical grade cotton tissue packed inside the foil package. This is inserted into the end of the condom body and used to push the condom into the vagina. Each condom is individually packaged without prior lubrication. However, lubricant is expected to be used at donning the condom and during sexual intercourse. The lubricant will be supplied in separate packets together with the condom. Unlike latex, polyurethane condoms are unlikely to cause any allergic reaction and are much stronger than conventional latex condoms

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: FC2 Female Condom
Description: FC2: 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 (Conformité Européenne) of the European Union. The FC2 is the only female condom that has been pre-qualified by the World Health Organisation. The device is similar in design to the FC1, but is made from a synthetic polymer (nitrile) film that is softer and more elastic than the polyurethane of the earlier device. 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 polyurethane ring is removable and serves as the insertion mechanism and anchors the device within the vagina. FC2 measures 180mm in length and 80mm in lay-flat width. The device is pre-lubricated with dimethicone.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: FC2 Female Condom
Description: FC2: 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 (Conformité Européenne) of the European Union. The FC2 is the only female condom that has been pre-qualified by the World Health Organisation. The device is similar in design to the FC1, but is made from a synthetic polymer (nitrile) film that is softer and more elastic than the polyurethane of the earlier device. 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 polyurethane ring is removable and serves as the insertion mechanism and anchors the device within the vagina. FC2 measures 180mm in length and 80mm in lay-flat width. The device is pre-lubricated with dimethicone.