A Clinical Investigation to Assess the Performance of Natural Rubber Latex Condoms in Couples

NCT03739190 | Completed Phase 4

• 1 other identifier: 5005901
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation is designed to evaluate the performance rate of a new natural rubber latex (NRL) male condom.

Conditions

Control of Pregnancy; Prevention of Sexually Transmitted Infections

Outcome Measures

Primary Outcomes (1)

• Compared clinical failure rate of condom use between the test condom group and the reference condom A group

  Number of clinical failure events, defined in ISO 29943-1:2017, will be reported by participants. Clinical failure rate is calculated as the number of condoms with at least 1 acute failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. A condom that experiences multiple clinical failure events only counts as a single clinical failure.

  within 2 hours following each coital act for each condom use

Secondary Outcomes (4)

• Compared clinical failure rate of condom use between the test condom group and the reference condom B group

  within 2 hours following each coital act for each condom use

• Compared clinical failure rate of condom use between the test condom group, the reference condom A group and reference condom B group

  within 2 hours following each coital act for each condom use

• Incidence of treatment-emergent adverse events and adverse device effects, defined in MEDDEV 2.7/3

  16 weeks

• Subject's experience on the use of each type of condoms [Acceptability and Tolerability]

  16 weeks

Study Arms (3)

Test Condom: Thin NRL Condom

EXPERIMENTAL

Following randomisation each couple will be given one set of 7 condoms as per randomisation schedule. Couples will return to the clinic site for collection of their next set of condoms on two additional occasions. Each couple will test a maximum of 21 condoms during their participation in the investigation.

Device: NRL Condom

Reference condom A: Medium Thickness NRL Condom

ACTIVE COMPARATOR

Device: NRL Condom

Reference condom B: Thick NRL Condom

ACTIVE COMPARATOR

Device: NRL Condom

Interventions

NRL Condom DEVICE

A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to Subjects to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 3 condom types.

Reference condom A: Medium Thickness NRL Condom; Reference condom B: Thick NRL Condom; Test Condom: Thin NRL Condom

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A male and a female subject aged: 18 - 60 years inclusive.
• All subjects must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months.
• 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).
• The female partner should use one other established highly effective form of non-barrier contraception, unless post-menopausal.
• 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.

You may not qualify if:

• 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.
• Either partner has a pre-existing skin condition (severe eczema/psoriasis) or systemic allergic reactions or as confirmed by the subject and physical examination.
• 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.
• 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.
• Male partners that have known erectile or ejaculatory dysfunction.
• 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.
• 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.
• 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.
• 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.
• 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.
• Either partner intends to continue to use antihistamines, anti-inflammatory drugs or pain killers for the duration of the investigation.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, Thailand

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each condom will be contained within an individual foil packet on which all branding will been masked. All the condom types will be masked in the same manner and identical boxes will be used for the test and comparator condoms A and B.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The condom types will be tested in a three-way cross-over design where couples will be randomised to use each of the three condom types in a defined order, according to the randomisation schedule.

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 13, 2018
• Study Start: July 22, 2019
• Primary Completion: December 27, 2019
• Study Completion: December 27, 2019
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

TH (1)