Clinical trial: A Clinical Investigation to Assess the Performance of Natural Rubber Latex Condoms in Couples (NCT03739190)

Eligibility criteria:
Inclusion Criteria:

          1. A male and a female subject aged: 18 - 60 years inclusive.

          2. All subjects must be generally healthy and in a mutually monogamous heterosexual
             relationship - current relationship ≥ 3 months.

          3. All couples must be sexually active, and agree to have penile-vaginal intercourse with
             a frequency sufficient to meet protocol requirements (a minimum of 5 coital acts over
             4 weeks).

          4. The female partner should use one other established highly effective form of
             non-barrier contraception, unless post-menopausal.

          5. Couples must agree not to use drugs or non-investigational devices that can affect
             sexual performance e.g. medication/medical devices used to treat erectile dysfunction.

        Exclusion Criteria:

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

          2. Either partner has a pre-existing skin condition (severe eczema/psoriasis) or systemic
             allergic reactions or as confirmed by the subject and physical examination.

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

          4. Subjects that have previous or planned genital surgery, that in the opinion of the
             Investigator would consider the subject unsuitable to participate in the clinical
             investigation e.g. laser for abnormal smear.

          5. Male partners that have known erectile or ejaculatory dysfunction.

          6. Either partner that requires to use/is using medication or preparations that are
             applied topically to the genitalia area or intravaginally other than that supplied for
             the investigation.

          7. 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 the
             investigator, deems the partner unsuitable for the investigation.

          8. Any participant who has clinical symptoms or signs of a sexually transmitted diseases
             (STD) or HIV/AIDS or has a previous history of high risk behaviour as judged by the
             investigator.

          9. Female partner using medication which in the investigators opinion would affect
             vaginal mucosal secretion, such as Chlorpheniramine at any time in the 14 days (or 5
             half-lives of the drug, whichever is longer) before first condom use.

         10. A male partner with abnormal penile anatomy that would, in the opinion of the
             investigator, affect the ability to keep the condom in place during intercourse.

         11. Either partner intends to continue to use antihistamines, anti-inflammatory drugs or
             pain killers for the duration of the investigation.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Contradiction