Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom

NCT05912283 | Completed FDA Device

• 1 other identifier: Karex02
• Study Type: interventional
• Target: 600
• Locations: 2 countries
• Sites: 3

Brief Summary

This is a multi-site, randomised 3-period cross-over trial evaluating the functional performance of two synthetic nitrile male condoms against a control latex male condom.

Conditions

Sexually Transmitted Diseases

Keywords

Synthetic Male Condom; Slippage-Breakage Study

Outcome Measures

Primary Outcomes (3)

• Clinical breakage

  Clinical breakage is defined as breakage or tearing during sexual intercourse or during withdrawal of the male condom from the vagina. Clinical breakage is breakage with potential adverse clinical consequences. The clinical breakage rate is calculated by dividing the number of male condoms reported to have broken or torn during sexual intercourse or during withdrawal by the number of male condoms used during vaginal intercourse.

  3 - 5 months

• Clinical slippage

  Clinical slippage is defined as a condom slipping completely off the penis during sexual intercourse or during withdrawal from the vagina. The clinical slippage rate is calculated by dividing the number of male condoms that slipped by the number of male condoms used during vaginal intercourse.

  3 - 5 months

• Clinical failure

  A Clinical failure is defined as a clinical breakage or a clinical slippage. The clinical failure rate is calculated by dividing the number of male condoms with a clinical failure by the number of male condoms used during vaginal intercourse.

  3 - 5 months

Secondary Outcomes (4)

• Genital discomfort

  3 - 5 months

• Acceptability

  3 - 5 months

• Non-Clinical breakage

  3 - 5 months

• Non-Clinical slippage

  3 - 5 months

Study Arms (3)

Synthetic Nitrile Condoms (53mm)

EXPERIMENTAL

53mm width synthetic nitrile condoms

Device: Synthetic Nitrile Condoms (53mm)

Synthetic Nitrile Condoms (56mm)

EXPERIMENTAL

56mm width synthetic nitrile condoms

Device: Synthetic Nitrile Condoms (56mm)

Control Latex Condom

ACTIVE COMPARATOR

Commercial natural rubber latex condom

Device: Control Latex Condom

Interventions

Synthetic Nitrile Condoms (53mm) DEVICE

53mm width synthetic nitrile condoms

Synthetic Nitrile Condoms (53mm)

Synthetic Nitrile Condoms (56mm) DEVICE

56mm width synthetic nitrile condoms

Synthetic Nitrile Condoms (56mm)

Control Latex Condom DEVICE

Commercial natural rubber latex condom

Control Latex Condom

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be between the ages of 18 and 45 years (inclusive);
• Be literate (able to read a newspaper or letter easily);
• Have been in an exclusive (monogamous) sexual relationship with partner for at least 3 months; and intend to continue to be an exclusive (monogamous) sexual relationship with their spouse or partner while participating in this research study;
• Be sexually active (defined as having at least one vaginal coital act per week);
• Willing to give informed consent;
• Willing to complete the male condom coital use reports;
• Willing to use the study condoms as directed;
• Agree to use only the study lubricant provided;
• Agree to only use the study condoms sequentially during time of participation
• Willing to adhere to the follow-up schedule and all study procedures;
• Willing to provide research study staff with an address, phone number or other locator information while participating in the study;
• Willing to participate in the study for the duration of 15 condom uses (approximately 3-5 months);
• Willing to provide photo identification and/or have fingerprint scan to exclude co-enrolment in other research projects;
• Female partner using hormonal or other non-barrier contraception (e.g. OCs, injectable, implant, IUD, or have had a tubal sterilization) or male partner vasectomised;
• Agree to return any unopened condoms;

You may not qualify if:

• Female partner is pregnant or desires to become pregnant during the time of the research study;
• Either partner is known to be HIV positive (based on self report \[EAH\] or documented HIV-negative test result within past two months \[MRU\]);
• Self-reported history of recurrent sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia);
• Male partner has known erectile or ejaculatory dysfunction;
• Either partner has genital piercing jewelry, uses genital beading or uses sex toys, drugs, medications or non-study devices that can affect sexual performance;
• Either partner has known sensitivities or allergies to latex, synthetic nitrile, vaginal/sexual lubricants or lubricants used on condoms;
• Either partner reports symptoms of STI (EAH) or has observable evidence of STI as determined through syndromic diagnosis and vaginal/penile examination (MRU);
• Either partner is currently participating in another condom study;
• Either partner is a past or current employee of Essential Access Health, University of the Witwatersrand, or Karex;
• Either partner is a sex worker.

Sponsors & Collaborators

• Karex Industries Sdn. Bhd.: lead
• University of Witwatersrand, South Africa: collaborator
• Essential Access Health: collaborator
• Sigma3 Services SARL: collaborator

Study Sites (3)

Essential Access Health

Berkeley, California, 94710, United States

Location

Essential Access Health

Los Angeles, California, 90010, United States

Location

MRU (MatCH Research Unit)

Durban, KwaZulu-Natal, 4001, South Africa

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mags Beksinska, PhD

  MatCH Research Unit (MRU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each product will be labeled with a randomly generated code.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A sequential randomised 3-period cross-over trial comparing the functional performance of two synthetic male condoms against a control latex male condom.

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: June 2, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1); US (2)