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| Name | Class |
|---|---|
| Essential Access Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Couples who use condom | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HydroGlyde Condom | Device | 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. |
| 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 |
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Inclusion Criteria:
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:
We are recruiting heterosexual couples: 1 female and 1 male
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essential Access Health | Los Angeles | California | 90010 | United States |
All information will only be shared by the sponsor (HydroGlyde Coatings, LLC) and clinical investigator (Essential Access Health).
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 5, 2022 | |
| Reset | May 17, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 5, 2022 | May 17, 2023 |
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