Synthetic Male Condom Slippage-Breakage Study

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: Completed
• Conditions: Sexually Transmitted Diseases; Contraceptive
• Intervention / Treatment: Device: Test Product; Device: Control Product

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: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94710
      • Essential Access Health
    • Los Angeles, California, United States, 90010
      • Essential Access Health

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Total Clinical Failure Rate	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

Outcome Measure	Measure Description	Time Frame
Clinical Breakage Rate	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	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

• Sponsor: Church & Dwight Company, Inc.
• Collaborators: Essential Access Health
• Investigators: Principal Investigator: Terri Walsh, MPH, Essential Access Health

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): May 12, 2023

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Synthetic Male Condom; Slippage-Breakage Study; ISO 29943-1
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases
• Other Study ID 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