A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.

Inclusion criteria

• ✓. Both partners participating must provide written informed consent.
• ✓. Couples must include a male and female within a heterosexual couple and be between 18 - 60 years of age inclusive.
• ✓. Both partners must be willing to respond to questions about their reproductive and contraceptive history and use of condoms during interviews and respond to self-administered questionnaires as per instructions.
• ✓. Both partners must agree to answer the questions in the condom use questionnaires and two scales as soon as possible and within 2 (+6) hours following each coital act.
• ✓. Both partners must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months.
• ✓. All couples must be averaging one act of intercourse weekly, agree to have penile-vaginal intercourse with a frequency sufficient to meet CIP requirements (a minimum of 5 coital acts over 5 weeks per assessment period-).
• ✓. The female partner must also use an established (as agreed by the Investigator) other highly effective form of non-barrier contraception, unless post-menopausal (confirmed menopausal prior to screening, amenorrhea for at least 12 months after cessation of exogenous hormone treatment) in which case no second form of contraception is required. Highly effective non-barrier contraception includes oral contraceptive (oestrogen and progestogen or progestogen-only hormonal contraception associated with inhibition of ovulation), intra-uterine device (IUD) or intra-uterine system (IUS), hormonal implant, injectables, patch and or sterilization of at least one partner (i.e., bilateral tubal ligation, vasectomy deemed medically successful).