Condom UsersEarly Phase 1NCT05308992
User Preference Study of an Experimental HydroGlyde Male Condom Compared to a Commercial Latex Male Condom
A Early Phase 1 study testing HydroGlyde Condom in people with Condom Users, run by HydroGlyde Coatings, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Condom Users
- What is being tested?
- HydroGlyde Condom
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 30 Apr 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 45 years (inclusive)
- Willing and able to give signed informed consent.
- 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.
- Have vaginal intercourse at least once weekly.
- Protected against pregnancy by oral contraceptives, an intrauterine device, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy).
- Willing to use the study products for four acts of vaginal intercourse within three weeks of study entry.
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- In a mutually monogamous relationship with their study partner for at least 6 months and be willing to remain mutually monogamous throughout study participation.
- Agree not to wear any genital piercing jewelry or use sex toys while using the study condoms.
- 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.
- Agree not to use alcohol in amounts that could enhance or diminish sexual response when using the condoms.
- 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.
- Willing to participate in either in-person visits or remote study visits conducted via videoconference and telephone and curbside exchange.
- Agree to complete online questionnaires after testing each study product and group of study products.
- Male partner agrees to ejaculate during vaginal intercourse. q. Willing to complete interviews by phone or video with HydroGlyde Coatings representatives.
- Each partner has used 10 or more male condoms in their lifetime. s. Willing to sign a confidentiality agreement pertaining to the study condoms.
Who cannot join
- Currently participating in another clinical study.
- Female partner self-reported as pregnant.
- Allergic to natural rubber latex or has a history of recurrent adverse events following use of latex products.
- Known allergy or skin sensitivity to common cosmetics and/or contact lens solutions or polyvinylpyrrolidone (PVP).
- Unable to follow instructions or strictly adhere to the study schedule.
- 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).
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- Currently using condoms for protection against a known sexually transmitted infection.
- Taking any internally 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 under typical circumstances/conditions.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Essential Access Health
Los Angeles, California, 90010
About this study
Official title: 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.
Read the 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.
- Conditions
- Condom Users
- Being tested
- HydroGlyde Condom
- Keywords
- Condom Use, Latex condoms, Lubrication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroGlyde CondomDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HydroGlyde Condom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Mar 2022
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condom UsersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HydroGlyde Coatings, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Essential Access Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308992
- Sponsor's protocol ID
- HGC-002
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All information will only be shared by the sponsor (HydroGlyde Coatings, LLC) and clinical investigator (Essential Access Health).
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Preference Study of 60 Couples Using an Experimental HydroGlyde Male Condom Compared to a Commercial Latex Male Condom
- ClinicalTrials.gov ID
- NCT05308992
- Acronym / sponsor ID
- HGC-002
- Conditions
- Condom Users
- Keywords
- Condom Use, Latex condoms, Lubrication
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- HydroGlyde Coatings, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Essential Access Health
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Couples who use condom | Other | Device: HydroGlyde CondomThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Between the ages of 18 and 45 years (inclusive)
- Willing and able to give signed informed consent.
- 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.
- Have vaginal intercourse at least once weekly.
- Protected against pregnancy by oral contraceptives, an intrauterine device, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy).
Key exclusion criteria (10 listed)
- Currently participating in another clinical study.
- Female partner self-reported as pregnant.
- Allergic to natural rubber latex or has a history of recurrent adverse events following use of latex products.
- Known allergy or skin sensitivity to common cosmetics and/or contact lens solutions or polyvinylpyrrolidone (PVP).
- Unable to follow instructions or strictly adhere to the study schedule.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroGlyde CondomThe 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. | Device | Couples who use condom |
Primary outcome
User Preference to demonstrate feasibility of the prototoype
Time frame: 2-3 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No. All information will only be shared by the sponsor (HydroGlyde Coatings, LLC) and clinical investigator (Essential Access Health).
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HydroGlyde Condom in people with Condom Users, run by HydroGlyde Coatings, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User Preference to demonstrate feasibility of the prototoype (time frame: 2-3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022; AzTrials last refreshed its copy on 1 Nov 2026.