Synthetic Male Condom Slippage-Breakage Study

November 7, 2023 updated by: Church & Dwight Company, Inc.

Evaluation of the Functional Performance and Acceptability of a Synthetic Male Condom as Compared to a Commercial Latex Condom (Trojan-Enz)

This is a multi-site, double-blind, crossover, randomized phase II study to evaluate the functional performance of a synthetic male condom as compared to a marketed latex 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

Approximately 300 heterosexual monogamous couples not at risk of pregnancy or transmission of sexually transmitted infections (STI) will be recruited to use both the test (synthetic) condom and a control (latex) condom. Couples will be given 4 condoms of one type (randomly determined) to use over a two week period, followed by 4 condoms of the other type to be used over the next two week period. The number of clinical failures (either condom breaks or completely slips off the penis) for each condom type will be compared to determine whether the test condom is non-inferior to the control condom. The study plan is based on International Standards Organization (ISO) guidance document ISO 29943-1 with the action standard set by synthetic condom standard ISO 23409.

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 Locations

  • 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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Willing and able to give written or electronic informed consent
  • Willing to respond to questions concerning participant's reproductive and contraceptive history and use of condoms contained either on self-administered surveys or interviews
  • Agree to have vaginal intercourse at least once weekly
  • Protected against pregnancy by oral contraceptives, an intrauterine device (IUD), an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
  • Willing to use the study products for eight acts of vaginal intercourse within four weeks of study entry
  • In a mutually monogamous relationship with participant's study partner for at least 3 months prior to screening and be willing to remain mutually monogamous throughout study participation
  • Agree not to use any vaginal or sexual lubricant except the product supplied by the study (AstroglideTM)
  • Agree not to wear any genital piercing jewellery while using the study condoms
  • Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms
  • Agree to return any unopened condoms
  • Reachable by telephone
  • Has home internet access, a valid personal email for each partner, ability to videoconference and use electronic signature technology
  • Male partner agrees to ejaculate during vaginal intercourse

Exclusion Criteria:

  • Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health
  • Female partner self-reported as pregnant
  • Allergic to natural rubber latex or styrene-isoprene-styrene (SIS), or has a history of recurrent adverse events following use of latex or SIS products
  • Unable to follow instructions or strictly adhere to the visit schedule
  • At significant (high) risk of sexually transmitted infections, including human immunodeficiency virus (HIV) infection or having a medical history of recurrent, serious sexually transmitted infection (e.g., gonorrhea, syphilis, Chlamydia)
  • Currently using condoms for protection against a known sexually transmitted infection
  • Taking any externally applied medication or oral medication to treat a genital condition
  • Male partner has had difficulty achieving or maintaining an erection or achieving ejaculation in the last month prior to screening under typical circumstances/ conditions.
  • Any self-reported genital condition (e.g., itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect the use of the study condoms or the ability to interpret study data

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: Test Product
Synthetic Male Condom
Device: Test Product
Synthetic Male Condom
Other Names:
  • Synthetic Male Condom
Active Comparator: Control Product
Latex Male Condom
Device: Control Product
Latex Male Condom
Other Names:
  • Latex Male 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
Total Clinical Failure Rate
Time Frame: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.
The number of condoms that broke or slipped completely off the penis during intercourse or withdrawal divided by the number of condoms used for vaginal intercourse.
Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.

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
Clinical Breakage Rate
Time Frame: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.
The number of condoms that broke during intercourse or withdrawal divided by the number of condoms used for vaginal intercourse.
Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.
Clinical Complete Slippage Rate
Time Frame: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.
The number of condoms that slipped completely off the penis during intercourse or withdrawal divided by the number of condoms used for vaginal intercourse.
Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.

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.
Church & Dwight Company, Inc.

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.
Essential Access Health

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: Terri Walsh, MPH, Essential Access Health

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 10, 2022

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 13, 2023

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.
May 12, 2023

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).
May 4, 2022

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.
May 6, 2022

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.
May 11, 2022

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.
November 8, 2023

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.
November 7, 2023

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.
November 1, 2023

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.
  • ST-21-U71

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

If the participants enroll in this study, study staff will collect personal information about the participants. Study staff will protect information about participants and participant participation in this research study to the best of study staff ability. Study staff will assign participants a study number that study staff will use on all data collection forms in place of participants' names. Participant initials and date of birth may also be used on study forms to identify participants. If the results of this research are published, participants' names will not be shown. Study staff will follow institutional procedures for protecting privacy and promoting security during office, curbside exchange and videoconference visits.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings