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

NCT06557499 | Recruiting FDA Device

• 1 other identifier: 2628301
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

This investigation is designed to evaluate the performance rate of two polyurethane male condoms with different sizes and thicknesses versus a standard natural rubber latex (NRL) male condom. The purpose of this study is to see how well the experimental condoms perform compared to the latex rubber condom (for example, how often the different condom types break or slip off the penis). Sponsor also wants to find out how well couples like using the three condom types and whether they experience any problems when using the condoms (for example, irritation or discomfort).

Conditions

Contraception

Keywords

Condoms; Slippage; Breakage

Outcome Measures

Primary Outcomes (2)

• Total clinical failure rate of Polyurethane (PU) male (Test condom 1) condom compared to Natural Rubber Latex (NRL) male condom.

  The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 1) compared to the NRL male control condom. Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, will be reported by participants.

  within 8 hours following each coital act for each condom use

• Total clinical failure rate of Polyurethane (PU) male (Test condom 2) condom compared to Natural Rubber Latex (NRL) male condom.

  The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 2) compared to the NRL male control condom. Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, will be reported by participants.

  within 8 hours following each coital act for each condom use

Secondary Outcomes (8)

• Clinical breakage rate of PU Male Test Condom 1 compared to NRL male control condom

  within 8 hours following each coital act for each condom use

• Clinical slippage rate of PU Male Test Condom 1 compared to NRL male control condom

  within 8 hours following each coital act for each condom use

• Clinical breakage rate of PU Male Test Condom 2 compared to NRL male control condom

  within 8 hours following each coital act for each condom use

• Clinical slippage rate of PU Male Test Condom 2 compared to NRL male control condom

  within 8 hours following each coital act for each condom use

• Non-clinical breakage rate for each of the PU male condoms (test condom 1 and test condom 2) and the NRL male control condom.

  within 8 hours following each coital act for each condom use

Study Arms (3)

Polyurethane (PU) male condom-Test condom 1

EXPERIMENTAL

Device: Polyurethane (PU) male condom-Test condom 1

Polyurethane (PU) male condom-Test condom 2

EXPERIMENTAL

Device: Polyurethane (PU) male condom-Test condom 2

Natural Rubber Latex (NRL) male condom- Control condom

ACTIVE COMPARATOR

Device: Natural Rubber Latex (NRL) male condom- Control condom

Interventions

Polyurethane (PU) male condom-Test condom 1 DEVICE

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

Polyurethane (PU) male condom-Test condom 1

Polyurethane (PU) male condom-Test condom 2 DEVICE

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

Polyurethane (PU) male condom-Test condom 2

Natural Rubber Latex (NRL) male condom- Control condom DEVICE

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

Natural Rubber Latex (NRL) male condom- Control condom

Eligibility Criteria

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

You may qualify if:

• 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).
• Both partners must be able to understand instructions for correct use of condoms.
• Both partners must have an adequate level of literacy to understand and to be able to answer the questionnaires.
• Both partners must agree to use only the investigational condoms during the time of participation.
• Participants must agree to use the penis measuring kit provided to measure the erect penis at investigation start.
• Both partners must agree not to use drugs or non-investigational devices that can affect sexual performance.
• Both partners must have no known sexually transmitted infections including Human Immunodeficiency Virus (HIV) / acquired immune deficiency syndrome (AIDS) (medical history via self-report) (uncomplicated Herpes simplex virus (HSV) and positive Human papillomavirus (HPV) which areis asymptomatic may be included in the investigation study in the opinion of the Investigator).
• Both partners must agree to use only lubricant(s) provided for the duration of investigation.
• Both partners must agree not to wear any genital piercing jewellery for the duration of the clinical investigation.

You may not qualify if:

• Either partner is or becomes aware of an allergy or sensitivity to the ingredients of any of the products, including the test or control condoms or any lubrication products provided.
• Either partner has been receiving daily treatment for their pre-existing skin condition (for example, severe eczema/psoriasis) within the three months prior to the screening for this study.
• Female partner that is pregnant or desires to become so while participating in investigation, (females of childbearing potential must have a negative pregnancy test as part of screening).
• Any couple undergoing any form of fertility treatment such as in-vitro fertilisation.
• Either partner needs to use condoms for sexually transmitted infection (STI) protection (e.g., discordance for Human Immunodeficiency Virus (HIV) or herpes).
• Either partner has previous or planned genital surgery that in the opinion of the Investigator would consider the participant unsuitable to participate in the clinical investigation (e.g., laser for abnormal smear).
• Either partner are commercial sex workers.
• Either partner are itinerant persons who will be unable to complete the clinical investigation (e.g., migrant farm workers).
• Couples that in the opinion of the Investigator, would be unable to complete the investigation.
• Male partners that have known erectile or ejaculatory dysfunction in the past month.
• Either partner 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.
• Either partner uses any medication which in the investigator's opinion may interfere with the use of condoms.
• A male partner with abnormal penile anatomy or genital lesion (e.g., balanoposthitis) that would, in the opinion of the Investigator, affect the ability to keep the condom in place during intercourse.
• Either partner is suffering from any health conditions (self-reported) or any condition which could, in the opinion of the Investigator, affect the outcome of the investigation or affect their safety if they participate.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (3)

Essential Access Health-Berkeley

Berkeley, California, 90010, United States

RECRUITING

Essential Access Health -Los Angeles

Los Angeles, California, 90017, United States

RECRUITING

Essential Acess Health- Seattle

Seattle, Washington, 98005, United States

RECRUITING

MeSH Terms

Interventions

Condoms

Intervention Hierarchy (Ancestors)

Contraceptive Devices, Male; Contraceptive Devices; Equipment and Supplies

Study Officials

• Terri Walsh

  Essential Access Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Terri Walsh

CONTACT

+1 213 386 5614; twalsh@essentialaccess.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical investigation is designed to be a data analyst-masked investigation where the data analyst who will perform the data analysis (both CRO and Sponsor staff involved in analysing the data) will not know which condom type couples have been randomised to use in each assessment period.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The condom types will be tested in a 3-way cross-over design where couples will be randomised to use each of the 3 condom types in a defined order, according to the randomisation schedule.

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 16, 2024
• Study Start: August 23, 2024
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)