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:

1. Both partners participating must provide written informed consent.

2. Couples must include a male and female within a heterosexual couple and be between 18 - 60 years of age inclusive.

3. Both partners must be willing to respond to questions about their reproductive andcontraceptive history and use of condoms during interviews and respond toself-administered questionnaires as per instructions.

4. Both partners must agree to answer the questions in the condom use questionnairesand two scales as soon as possible and within 2 (+6) hours following each coitalact.

5. Both partners must be generally healthy and in a mutually monogamous heterosexualrelationship - current relationship ≥ 3 months.

6. All couples must be averaging one act of intercourse weekly, agree to havepenile-vaginal intercourse with a frequency sufficient to meet CIP requirements (aminimum of 5 coital acts over 5 weeks per assessment period-).

7. 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 aftercessation of exogenous hormone treatment) in which case no second form ofcontraception is required. Highly effective non-barrier contraception includes oralcontraceptive (oestrogen and progestogen or progestogen-only hormonal contraceptionassociated with inhibition of ovulation), intra-uterine device (IUD) orintra-uterine system (IUS), hormonal implant, injectables, patch and orsterilization of at least one partner (i.e., bilateral tubal ligation, vasectomydeemed medically successful).

8. Both partners must be able to understand instructions for correct use of condoms.

9. Both partners must have an adequate level of literacy to understand and to be ableto answer the questionnaires.

10. Both partners must agree to use only the investigational condoms during the time ofparticipation.

11. Participants must agree to use the penis measuring kit provided to measure the erectpenis at investigation start.

12. Both partners must agree not to use drugs or non-investigational devices that canaffect sexual performance.

13. Both partners must have no known sexually transmitted infections including HumanImmunodeficiency Virus (HIV) / acquired immune deficiency syndrome (AIDS) (medicalhistory via self-report) (uncomplicated Herpes simplex virus (HSV) and positiveHuman papillomavirus (HPV) which areis asymptomatic may be included in theinvestigation study in the opinion of the Investigator).

14. Both partners must agree to use only lubricant(s) provided for the duration ofinvestigation.

15. Both partners must agree not to wear any genital piercing jewellery for the durationof the clinical investigation.

16. Both partners must have no past medical history of any health condition (self-reported) that, in the opinion of the Investigator, would be consideredclinically relevant.

17. Couples must have a compatible electronic device with internet access which they arewilling to upload questionnaire data to the web-based platform throughout theinvestigation.

18. Both partners will be available for follow-up.

Exclusion Criteria:

1. Either partner is or becomes aware of an allergy or sensitivity to the ingredientsof any of the products, including the test or control condoms or any lubricationproducts provided.

2. Either partner has been receiving daily treatment for their pre-existing skincondition (for example, severe eczema/psoriasis) within the three months prior tothe screening for this study.

3. Female partner that is pregnant or desires to become so while participating ininvestigation, (females of childbearing potential must have a negative pregnancytest as part of screening).

4. Any couple undergoing any form of fertility treatment such as in-vitrofertilisation.

5. Either partner needs to use condoms for sexually transmitted infection (STI)protection (e.g., discordance for Human Immunodeficiency Virus (HIV) or herpes).

6. Either partner has previous or planned genital surgery that in the opinion of theInvestigator would consider the participant unsuitable to participate in theclinical investigation (e.g., laser for abnormal smear).

7. Either partner are commercial sex workers.

8. Either partner are itinerant persons who will be unable to complete the clinicalinvestigation (e.g., migrant farm workers).

9. Couples that in the opinion of the Investigator, would be unable to complete theinvestigation.

10. Male partners that have known erectile or ejaculatory dysfunction in the past month.

11. Either partner requires to use/ is using medication or preparations that are appliedtopically to the genitalia area or intravaginally, other than that supplied for theinvestigation.

12. A female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness) in the previous 3 months which, in the opinion of theInvestigator, deems the partner unsuitable for the investigation.

13. Either partner uses any medication which in the investigator's opinion may interferewith the use of condoms.

14. A male partner with abnormal penile anatomy or genital lesion (e.g.,balanoposthitis) that would, in the opinion of the Investigator, affect the abilityto keep the condom in place during intercourse.

15. Either partner is suffering from any health conditions (self-reported) or anycondition which could, in the opinion of the Investigator, affect the outcome of theinvestigation or affect their safety if they participate.

16. Either partner have participated in a clinical trial in the previous month whichcould, in the opinion of the Investigator, affect the outcome of the investigation.

17. Either partner is an employee of the investigational Sponsor or affiliated with theclinical research centre (i.e., enrolment of the Investigator, his/ her familymembers, employees and other dependent persons).

18. Either partner has a recent history of drug/alcohol abuse within the previous 12months.

19. Either partner has an inability to follow the procedures of the investigation, (e.g., due to language problems, psychological disorders, health conditions such asdementia).

20. Either partner is unable, in the opinion of the Investigator, to fully comply withthe investigation requirements.