Synthetic Male Condom Slippage-Breakage Study

NCT05370196 | Completed FDA Device

• 1 other identifier: ST-21-U71
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Contraceptive; Sexually Transmitted Diseases

Keywords

Synthetic Male Condom; Slippage-Breakage Study; ISO 29943-1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical Breakage Rate

  Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.

• Clinical Complete Slippage Rate

  Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.

Study Arms (2)

Test Product

EXPERIMENTAL

Synthetic Male Condom

Device: Test Product

Control Product

ACTIVE COMPARATOR

Latex Male Condom

Device: Control Product

Interventions

Test Product DEVICE

Synthetic Male Condom

Also known as: Synthetic Male Condom

Test Product

Control Product DEVICE

Latex Male Condom

Also known as: Latex Male Condom

Control Product

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead
• Essential Access Health: collaborator

Study Sites (2)

Essential Access Health

Berkeley, California, 94710, United States

Location

Essential Access Health

Los Angeles, California, 90010, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Terri Walsh, MPH

  Essential Access Health

  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

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 11, 2022
• Study Start: June 10, 2022
• Primary Completion: January 13, 2023
• Study Completion: May 12, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)