User Preference Study of an Experimental HydroGlyde Male Condom Compared to a Commercial Latex Male Condom

User Preference Study of 60 Couples Using an Experimental HydroGlyde Male Condom Compared to a Commercial Latex Male Condom

Latex condoms have long been available as contraceptive devices as well as an effective means of preventing the spread of sexually transmitted infections. However, lack of adequate lubrication leads to inconsistent and incorrect condom use. The latex HydroGlyde condom has a hydrophilic coating which maintains its lubricity when in contact with water. Improved lubrication during intercourse may lead to improved user satisfaction and increased condom use which would help prevent the spread of Sexually Transmitted Infections and unwanted pregnancies.

The primary objective of this study is to evaluate the preference, performance (breakage, slippage), safety (adverse events) and acceptability of a HydroGlyde prototype condom compared to a commercial latex condom with silicone lubricant. A secondary objective of this study is to compare and evaluate various lubricant activation methods for reliability, usability, and user preference.

Study Overview

• Status: Enrolling by invitation
• Conditions: Condom Users
• Intervention / Treatment: Device: HydroGlyde Condom

Detailed Description

Latex condoms have long been available as contraceptive devices as well as an effective means of preventing the spread of sexually transmitted infections. However, lack of adequate lubrication leads to inconsistent and incorrect condom use. The latex HydroGlyde condom has a hydrophilic coating which maintains its lubricity when in contact with water. Improved lubrication during intercourse may lead to improved user satisfaction and increased condom use which would help prevent the spread of Sexually Transmitted Infections and unwanted pregnancies.

The primary objective of this study is to evaluate the preference, performance (breakage, slippage), safety (adverse events) and acceptability of a HydroGlyde prototype condom compared to a commercial latex condom with silicone lubricant. A secondary objective of this study is to compare and evaluate various lubricant activation methods for reliability, usability, and user preference.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • 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: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Between the ages of 18 and 45 years (inclusive)
2. Willing and able to give signed informed consent.
3. Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms contained on self-administered questionnaires, online questionnaires or in-person interviews.
4. Have vaginal intercourse at least once weekly.
5. Protected against pregnancy by oral contraceptives, an intrauterine device, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy).
6. Willing to use the study products for four acts of vaginal intercourse within three weeks of study entry.
7. In a mutually monogamous relationship with their study partner for at least 6 months and be willing to remain mutually monogamous throughout study participation.

i. Agree not to wear any genital piercing jewelry or use sex toys while using the study condoms.

j. Agree not to use drugs that could enhance or diminish sexual response, including testosterone, poppers, and drugs like Viagra and Cialis when using study condoms.

k. Agree not to use alcohol in amounts that could enhance or diminish sexual response when using the condoms.

l. Agree to return any unopened condoms m. Have home access to the internet, a valid personal email for each partner and be reachable by mobile phone.

n. Willing to participate in either in-person visits or remote study visits conducted via videoconference and telephone and curbside exchange.

o. Agree to complete online questionnaires after testing each study product and group of study products.

p. Male partner agrees to ejaculate during vaginal intercourse. q. Willing to complete interviews by phone or video with HydroGlyde Coatings representatives.

r. Each partner has used 10 or more male condoms in their lifetime. s. Willing to sign a confidentiality agreement pertaining to the study condoms.

Exclusion Criteria:

1. Currently participating in another clinical study.
2. Female partner self-reported as pregnant.
3. Allergic to natural rubber latex or has a history of recurrent adverse events following use of latex products.
4. Known allergy or skin sensitivity to common cosmetics and/or contact lens solutions or polyvinylpyrrolidone (PVP).
5. Unable to follow instructions or strictly adhere to the study schedule.
6. At significant (high) risk of sexually transmitted infections, including human immunodeficiency virus infection, or having a medical history of recurrent, serious sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia).
7. Currently using condoms for protection against a known sexually transmitted infection.
8. Taking any internally applied medication or oral medication to treat a genital condition.
9. Male partner has had difficulty achieving or maintaining an erection, or achieving ejaculation in the last month under typical circumstances/conditions.
10. Any self-reported genital condition (e.g. itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect use of the study condoms or the ability to interpret study data.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Couples who use condom; The investigator will recruit heterosexual couples who have experience using silicone-lubricated latex condoms. All couples are required to have a backup birth control option and must be monogamous to participate in the study.	Device: HydroGlyde Condom; The latex HydroGlyde condom has a hydrophilic coating which maintains its lubricity when in contact with water. Improved lubrication during intercourse may lead to improved user satisfaction and increased condom use which would help prevent the spread of Sexually Transmitted Infections and unwanted pregnancies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Preference to demonstrate feasibility of the prototoype	Couples comparing the comfort, lubrication, and experience with the HydroGlyde condom to a US leading silicone lubricated condom control. Couples will provide their feedback and experience in an online questionnaire and report which sample is most preferred.	2-3 weeks

Collaborators and Investigators

• Sponsor: HydroGlyde Coatings, LLC
• Collaborators: Essential Access Health

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Condom Use; Latex condoms; Lubrication
• Other Study ID Numbers: HGC-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: All information will only be shared by the sponsor (HydroGlyde Coatings, LLC) and clinical investigator (Essential Access Health).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes