Table 11 Noninferiority analyses

Primary analysis: polyurethane A versus Control Latex C

Couples

252

252

–

–

–

Condoms used

1193

1212

–

–

–

Total clinical failure (%)

28 (2.35)

16 (1.32)

1.03

(− 0.29, 2.35)

Rejected¹

Clinical breakage (%)

15 (1.26)

10 (0.83)

0.43

(− 0.61, 1.48)

Rejected²

Clinical slippage (%)

13 (1.09)

6 (0.50)

0.59

(− 0.19, 1.38)

Rejected²

Primary analysis: polyurethane B versus control latex C

Couples

247

247

–

–

–

Condoms used

1142

1193

–

–

–

Total clinical failure (%)

35 (3.06)

15 (1.26)

1.81

(0.39, 3.23)

Fail to Reject¹

Clinical breakage (%)

22 (1.93)

9 (0·75)

1.17

(− 0.03, 2.37)

Fail to Reject²

Clinical slippage (%)

13 (1.14)

6 (0.50)

0.64

(− 0.14, 1.41)

Rejected²

Post Hoc analysis: polyurethane B versus latex C with male partners penis length ≤ 170 mm

Couples

190

190

Condoms used

886

915

Total clinical failure (%)

20 (2.26)

11 (1.20)

1.06%

(− 0.26, 2.37)

Rejected¹

Clinical breakage (%)

12 (1.35)

5 (0.55)

0.81%

(− 0.23, 1.84)

Rejected²

Clinical slippage (%)

8 (0.90)

6 (0.66)

0.25%

(− 0.57, 1.06)

Rejected²