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

May 23, 2024 updated by: Karex Industries Sdn. Bhd.

A Functional Performance and Acceptability Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A sequential randomised 3-period cross-over trial comparing five uses of two synthetic nitrile male condoms of different sizes with a control latex male condom. Each couple will be asked to use five synthetic nitrile condoms (53 mm width), five synthetic nitrile condoms (56 mm width) and five latex male condoms (53 mm width) in a randomised order. Couples will complete a Condom Use Report after each condom use. Function, safety, and acceptability will be assessed at each of three follow-up visits conducted after using each set of five condoms. The trial will enrol 300 couples, anticipating that at least 255 couples will complete the study. Half of the couples (150) will be enrolled in Durban, South Africa and half (150) enrolled in California USA.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • South Africa
    • Kwa-Zulu Natal
      • Durban, Kwa-Zulu Natal, South Africa, 4001
        • MRU (MatCH Research Unit)
  • United States
    • California
      • Berkeley, California, United States, 94710
        • Essential Access Health
      • Los Angeles, California, United States, 90010
        • Essential Access Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Be between the ages of 18 and 45 years (inclusive);
  2. Be literate (able to read a newspaper or letter easily);
  3. 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;
  4. Be sexually active (defined as having at least one vaginal coital act per week);
  5. Willing to give informed consent;
  6. Willing to complete the male condom coital use reports;
  7. Willing to use the study condoms as directed;
  8. Agree to use only the study lubricant provided;
  9. Agree to only use the study condoms sequentially during time of participation
  10. Willing to adhere to the follow-up schedule and all study procedures;
  11. Willing to provide research study staff with an address, phone number or other locator information while participating in the study;
  12. Willing to participate in the study for the duration of 15 condom uses (approximately 3-5 months);
  13. Willing to provide photo identification and/or have fingerprint scan to exclude co-enrolment in other research projects;
  14. 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;
  15. Agree to return any unopened condoms;
  16. Male partner willing to ejaculate during vaginal intercourse;
  17. Male partner willing to hold on to the condom ring when withdrawing the erect penis after sexual intercourse;
  18. Agree to not bring study condoms in contact with genital or oral piercing jewelry
  19. EAH: Both partners have valid personal email and operable mobile phones;

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Synthetic Nitrile Condoms (53mm)
53mm width synthetic nitrile condoms
Device: Synthetic Nitrile Condoms (53mm)
53mm width synthetic nitrile condoms
Experimental: Synthetic Nitrile Condoms (56mm)
56mm width synthetic nitrile condoms
Device: Synthetic Nitrile Condoms (56mm)
56mm width synthetic nitrile condoms
Active Comparator: Control Latex Condom
Commercial natural rubber latex condom
Device: Control Latex Condom
Commercial natural rubber latex condom

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical breakage
Time Frame: 3 - 5 months
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
Time Frame: 3 - 5 months
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
Time Frame: 3 - 5 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Genital discomfort
Time Frame: 3 - 5 months
Rates of genital discomfort reported to have occurred during or immediately after condom use. Genital adverse events will be classified by relatedness, expectedness and severity.
3 - 5 months
Acceptability
Time Frame: 3 - 5 months
Frequency of key acceptability outcome measures will be calculated and include: comfort in use; ease of insertion and removal; like or dislike of product attributes; adequacy and feel of lubrication and sensitivity and stimulation.
3 - 5 months
Non-Clinical breakage
Time Frame: 3 - 5 months
Defined as breakage noticed before sexual intercourse or occurring after withdrawal of the male condom from the vagina. Non-clinical breakage is breakage with no potential adverse clinical consequences. The non-clinical breakage rate is calculated by dividing the number of male condoms reported to have broken before sexual intercourse or after withdrawal by the number of male condom packages opened.
3 - 5 months
Non-Clinical slippage
Time Frame: 3 - 5 months
Defined as slippage along the shaft of the penis during sexual intercourse (but not completely off the penis). Non-clinical slippage is slippage with no potential adverse clinical consequences. The non-clinical slippage rate is calculated by dividing the number of male condoms reported to have partially slipped during sexual intercourse by the number of male condoms used during vaginal intercourse.
3 - 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karex Industries Sdn. Bhd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Witwatersrand, South Africa
Essential Access Health
Sigma3 Services SARL

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mags Beksinska, PhD, MatCH Research Unit (MRU)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Karex02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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