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Official title A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.
ClinicalTrials.gov ID: NCT06557499
What this study is testing
- What it's testing
- This investigation is designed to evaluate the performance rate of two polyurethane male condoms with different sizes and thicknesses versus a standard natural rubber latex (NRL) male condom. The purpose of this study is to see how well the experimental condoms perform compared to the latex rubber condom (for example, how often the different condom types break or slip off the penis).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Both partners participating must provide written informed consent.
- Couples must include a male and female within a heterosexual couple and be between 18 - 60 years of age inclusive.
- Both partners must be willing to respond to questions about their reproductive and contraceptive history and use of condoms during interviews and...
- Both partners must agree to answer the questions in the condom use questionnaires and two scales as soon as possible and within 2 (+6) hours...
- Both partners must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months.
You likely can't join if
- Either partner is or becomes aware of an allergy or sensitivity to the ingredients of any of the products, including the test or control condoms or...
- Either partner has been receiving daily treatment for their pre-existing skin condition (for example, severe eczema/psoriasis) within the three...
- Female partner that is pregnant or desires to become so while participating in investigation, (females of childbearing potential must have a negative...
- Any couple undergoing any form of fertility treatment such as in-vitro fertilisation.
- Either partner needs to use condoms for sexually transmitted infection (STI) protection (e.g., discordance for Human Immunodeficiency Virus (HIV) or...
- Either partner has previous or planned genital surgery that in the opinion of the Investigator would consider the participant unsuitable to...
See the full eligibility criteria
Who can join
- Both partners participating must provide written informed consent.
- Couples must include a male and female within a heterosexual couple and be between 18 - 60 years of age inclusive.
- Both partners must be willing to respond to questions about their reproductive and contraceptive history and use of condoms during interviews and respond to self-administered questionnaires as per instructions.
- Both partners must agree to answer the questions in the condom use questionnaires and two scales as soon as possible and within 2 (+6) hours following each coital act.
- Both partners must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months.
- All couples must be averaging one act of intercourse weekly, agree to have penile-vaginal intercourse with a frequency sufficient to meet CIP requirements (a minimum of 5 coital acts over 5 weeks per assessment period-).
- The female partner must also use an established (as agreed by the Investigator) other highly effective form of non-barrier contraception, unless post-menopausal (confirmed menopausal prior to screening, amenorrhea for...
- Both partners must be able to understand instructions for correct use of condoms.
- Both partners must have an adequate level of literacy to understand and to be able to answer the questionnaires.
- Both partners must agree to use only the investigational condoms during the time of participation.
- Participants must agree to use the penis measuring kit provided to measure the erect penis at investigation start.
- Both partners must agree not to use drugs or non-investigational devices that can affect sexual performance.
- Both partners must have no known sexually transmitted infections including Human Immunodeficiency Virus (HIV) / acquired immune deficiency syndrome (AIDS) (medical history via self-report) (uncomplicated Herpes simplex...
- Both partners must agree to use only lubricant(s) provided for the duration of investigation.
- Both partners must agree not to wear any genital piercing jewellery for the duration of the clinical investigation.
- Both partners must have no past medical history of any health condition (self-reported) that, in the opinion of the Investigator, would be considered clinically relevant.
- Couples must have a compatible electronic device with internet access which they are willing to upload questionnaire data to the web-based platform throughout the investigation.
- Both partners will be available for follow-up.
What rules you out
- Either partner is or becomes aware of an allergy or sensitivity to the ingredients of any of the products, including the test or control condoms or any lubrication products provided.
- Either partner has been receiving daily treatment for their pre-existing skin condition (for example, severe eczema/psoriasis) within the three months prior to the screening for this study.
- Female partner that is pregnant or desires to become so while participating in investigation, (females of childbearing potential must have a negative pregnancy test as part of screening).
- Any couple undergoing any form of fertility treatment such as in-vitro fertilisation.
- Either partner needs to use condoms for sexually transmitted infection (STI) protection (e.g., discordance for Human Immunodeficiency Virus (HIV) or herpes).
- Either partner has previous or planned genital surgery that in the opinion of the Investigator would consider the participant unsuitable to participate in the clinical investigation (e.g., laser for abnormal smear).
- Either partner are commercial sex workers.
- Either partner are itinerant persons who will be unable to complete the clinical investigation (e.g., migrant farm workers).
- Couples that in the opinion of the Investigator, would be unable to complete the investigation.
- Male partners that have known erectile or ejaculatory dysfunction in the past month.
- Either partner requires to use/ is using medication or preparations that are applied topically to the genitalia area or intravaginally, other than that supplied for the investigation.
- A female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness) in the previous 3 months which, in the opinion of the Investigator, deems the partner unsuitable for the...
- Either partner uses any medication which in the investigator's opinion may interfere with the use of condoms.
- A male partner with abnormal penile anatomy or genital lesion (e.g., balanoposthitis) that would, in the opinion of the Investigator, affect the ability to keep the condom in place during intercourse.
- Either partner is suffering from any health conditions (self-reported) or any condition which could, in the opinion of the Investigator, affect the outcome of the investigation or affect their safety if they participate.
- Either partner have participated in a clinical trial in the previous month which could, in the opinion of the Investigator, affect the outcome of the investigation.
- Either partner is an employee of the investigational Sponsor or affiliated with the clinical research centre (i.e., enrolment of the Investigator, his/ her family members, employees and other dependent persons).
- Either partner has a recent history of drug/alcohol abuse within the previous 12 months.
- Either partner has an inability to follow the procedures of the investigation, (e.g., due to language problems, psychological disorders, health conditions such as dementia).
- Either partner is unable, in the opinion of the Investigator, to fully comply with the investigation requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Berkeley, California, United States
- Los Angeles, California, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berkeley, California, United States; Los Angeles, California, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.