Clinical trial NCT04134039: A Clinical Investigation to Assess the Performance of a Polyurethane Condom Versus a Latex Condom in Healthy Monogamous Couples
Official title: A Randomized, Assessor-masked, 2-way Cross-over, Multi-centre, Clinical Investigation to Evaluate the Performance Rate of a Polyurethane Condom in Healthy Monogamous Couples When Compared With a Standard Latex Condom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Control of Pregnancy
Prevention of Sexually Transmitted Infections
Lead sponsor: Reckitt Benckiser Healthcare (UK) Limited
Sponsor class: INDUSTRY
Collaborators: name: Novotech (Australia) Pty Limited
First posted: 2019-10-21
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The condom types will be tested in a 2-way cross-over design where couples will be randomised to use each of the 2 condom types in a defined order, according to the randomisation schedule.
Primary purpose: TREATMENT

Brief summary: This investigation is designed to evaluate the performance rate of a polyurethane (PU) condom versus a standard natural rubber latex (NRL) condom.

Detailed description: In this clinical investigation, a new PU male condom (test condom) will be evaluated against a marketed NRL male condom (reference condom). This clinical investigation will also evaluate the in-use tolerance of the test and reference condoms.

Eligibility criteria: Main 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 already be on an 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.

Main 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 reference condoms.
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. 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.
7. Any subject 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.
8. Female partner using medication which in the investigator's 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.
9. 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.
10. Either partner intends to continue to use antihistamines, anti-inflammatory drugs or pain killers for the duration of the investigation.

Primary outcomes:
measure: Compared clinical failure rate of condom use between the test condom group and the reference condom group
timeFrame: within 2 hours following each coital act for each condom use
Secondary outcomes:
measure: Performance (clinical slippage rate) of the Polyurethane (PU) condom
timeFrame: within 2 hours following each coital act for each condom use
measure: Performance (clinical slippage rate) of the Natural Rubber Latex (NRL) condom
timeFrame: within 2 hours following each coital act for each condom use
measure: Performance (clinical breakage rate) of the Polyurethane (PU) condom
timeFrame: within 2 hours following each coital act for each condom use
measure: Performance (clinical breakage rate) of the Natural Rubber Latex (NRL) condom
timeFrame: within 2 hours following each coital act for each condom use
measure: Incidence of treatment-emergent adverse events and adverse device effects, defined in MEDDEV 2.7/3
timeFrame: 12 weeks
measure: Subject's experience on the use of each type of condoms [Acceptability and Tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
affiliation: King Chulalongkorn Memorial Hospital
name: Unnop Jaisamrarn, MD
role: PRINCIPAL_INVESTIGATOR
References: