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Barrier Method

Couples who use condom for Condom Users

Phase < 1
Waitlist Available
Research Sponsored by HydroGlyde Coatings, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-3 weeks
Awards & highlights

Study Summary

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
User Preference to demonstrate feasibility of the prototoype

Trial Design

1Treatment groups
Experimental Treatment
Group I: Couples who use condomExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

HydroGlyde Coatings, LLCLead Sponsor
Essential Access HealthOTHER
6 Previous Clinical Trials
2,750 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~38 spots leftby May 2025