ContraceptiveNCT05370196
Synthetic Male Condom Slippage-Breakage Study
A study testing Test Product in people with Contraceptive and Sexually Transmitted Diseases, run by Church & Dwight Company, Inc. at 2 sites in United States.
Trial summary
This is a multi-site, double-blind, crossover, randomized phase II study to evaluate the functional performance of a synthetic male condom as compared to a marketed latex condom. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Contraceptive, Sexually Transmitted Diseases
- What is being tested?
- Test Product
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jun 2022to 12 May 2023
- Phase
- Interventional
- 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
- Willing and able to give written or electronic informed consent
- Willing to respond to questions concerning participant's reproductive and contraceptive history and use of condoms contained either on self-administered surveys or interviews
- Agree to have vaginal intercourse at least once weekly
- Protected against pregnancy by oral contraceptives, an intrauterine device (IUD), an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
- Willing to use the study products for eight acts of vaginal intercourse within four weeks of study entry
- In a mutually monogamous relationship with participant's study partner for at least 3 months prior to screening and be willing to remain mutually monogamous throughout study participation
Show all 13Show fewer
- Agree not to use any vaginal or sexual lubricant except the product supplied by the study (AstroglideTM)
- Agree not to wear any genital piercing jewellery while using the study condoms
- Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms
- Agree to return any unopened condoms
- Reachable by telephone
- Has home internet access, a valid personal email for each partner, ability to videoconference and use electronic signature technology
- Male partner agrees to ejaculate during vaginal intercourse
Who cannot join
- Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health
- Female partner self-reported as pregnant
- Allergic to natural rubber latex or styrene-isoprene-styrene (SIS), or has a history of recurrent adverse events following use of latex or SIS products
- Unable to follow instructions or strictly adhere to the visit schedule
- At significant (high) risk of sexually transmitted infections, including human immunodeficiency virus (HIV) infection or having a medical history of recurrent, serious sexually transmitted infection (e.g., gonorrhea, syphilis, Chlamydia)
- Currently using condoms for protection against a known sexually transmitted infection
Show all 9Show fewer
- Taking any externally 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 prior to screening under typical circumstances/ conditions.
- Any self-reported genital condition (e.g., itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect the use of the study condoms or the ability to interpret study data
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Essential Access Health
Berkeley, California, 94710
Essential Access Health
Los Angeles, California, 90010
About this study
Official title: Evaluation of the Functional Performance and Acceptability of a Synthetic Male Condom as Compared to a Commercial Latex Condom (Trojan-Enz)
This is a multi-site, double-blind, crossover, randomized phase II study to evaluate the functional performance of a synthetic male condom as compared to a marketed latex condom.
Read the detailed description
Approximately 300 heterosexual monogamous couples not at risk of pregnancy or transmission of sexually transmitted infections (STI) will be recruited to use both the test (synthetic) condom and a control (latex) condom. Couples will be given 4 condoms of one type (randomly determined) to use over a two week period, followed by 4 condoms of the other type to be used over the next two week period. The number of clinical failures (either condom breaks or completely slips off the penis) for each condom type will be compared to determine whether the test condom is non-inferior to the control condom. The study plan is based on International Standards Organization (ISO) guidance document ISO 29943-1 with the action standard set by synthetic condom standard ISO 23409.
- Conditions
- Contraceptive, Sexually Transmitted Diseases
- Being tested
- Test Product, Control Product
- Keywords
- Synthetic Male Condom, Slippage-Breakage Study, ISO 29943-1
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test ProductDevice
Also called Synthetic Male Condom
Synthetic Male Condom
Control ProductDevice
Also called Latex Male Condom
Latex Male Condom
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Synthetic Male Condom Receives: Device: Test Product |
| Control Product | Active comparator | Latex Male Condom Receives: Device: Control Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Clinical Failure Rate
The number of condoms that broke or slipped completely off the penis during intercourse or withdrawal divided by the number of condoms used for vaginal intercourse.
Measured: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.
Secondary outcomes (2)
Clinical Breakage Rate
The number of condoms that broke during intercourse or withdrawal divided by the number of condoms used for vaginal intercourse.
Measured: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.
Clinical Complete Slippage Rate
The number of condoms that slipped completely off the penis during intercourse or withdrawal divided by the number of condoms used for vaginal intercourse.
Measured: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start10 Jun 2022
- Primary completion13 Jan 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptiveStudies 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Essential Access Health
- Responsible party
- Sponsor
- Investigators
- Terri Walsh, MPH, Principal investigator, Essential Access Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370196
- Sponsor's protocol ID
- ST-21-U71
- Status last verified
- Nov 2023
- First submitted
- 4 May 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: If the participants enroll in this study, study staff will collect personal information about the participants. Study staff will protect information about participants and participant participation in this research study to the best of study staff ability. Study staff will assign participants a study number that study staff will use on all data collection forms in place of participants' names. Participant initials and date of birth may also be used on study forms to identify participants. If the results of this research are published, participants' names will not be shown. Study staff will follow institutional procedures for protecting privacy and promoting security during office, curbside exchange and videoconference visits.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Functional Performance and Acceptability of a Synthetic Male Condom as Compared to a Commercial Latex Condom (Trojan-Enz)
- ClinicalTrials.gov ID
- NCT05370196
- Acronym / sponsor ID
- ST-21-U71
- Conditions
- Contraceptive, Sexually Transmitted Diseases
- Keywords
- Synthetic Male Condom, Slippage-Breakage Study, ISO 29943-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Essential Access Health
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 11 May 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.
This is a multi-site, double-blind, crossover, randomized phase II study to evaluate the functional performance of a synthetic male condom as compared to a marketed latex condom.
Detailed description
Approximately 300 heterosexual monogamous couples not at risk of pregnancy or transmission of sexually transmitted infections (STI) will be recruited to use both the test (synthetic) condom and a control (latex) condom. Couples will be given 4 condoms of one type (randomly determined) to use over a two week period, followed by 4 condoms of the other type to be used over the next two week period. The number of clinical failures (either condom breaks or completely slips off the penis) for each condom type will be compared to determine whether the test condom is non-inferior to the control condom. The study plan is based on International Standards Organization (ISO) guidance document ISO 29943-1 with the action standard set by synthetic condom standard ISO 23409.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Device: Test ProductSynthetic Male Condom |
| Control Product | Active comparator | Device: Control ProductLatex Male Condom |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Willing and able to give written or electronic informed consent
- Willing to respond to questions concerning participant's reproductive and contraceptive history and use of condoms contained either on self-administered surveys or interviews
- Agree to have vaginal intercourse at least once weekly
- Protected against pregnancy by oral contraceptives, an intrauterine device (IUD), an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
- Willing to use the study products for eight acts of vaginal intercourse within four weeks of study entry
Key exclusion criteria (9 listed)
- Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health
- Female partner self-reported as pregnant
- Allergic to natural rubber latex or styrene-isoprene-styrene (SIS), or has a history of recurrent adverse events following use of latex or SIS products
- Unable to follow instructions or strictly adhere to the visit schedule
- At significant (high) risk of sexually transmitted infections, including human immunodeficiency virus (HIV) infection or having a medical history of recurrent, serious sexually transmitted infection (e.g., gonorrhea, syphilis, Chlamydia)
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 |
|---|---|---|
| Test ProductAlso: Synthetic Male CondomSynthetic Male Condom | Device | Test Product |
| Control ProductAlso: Latex Male CondomLatex Male Condom | Device | Control Product |
Primary outcome
Total Clinical Failure Rate
Time frame: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.
The number of condoms that broke or slipped completely off the penis during intercourse or withdrawal divided by the number of condoms used for vaginal intercourse.
2 secondary outcomes
Clinical Breakage Rate
Time frame: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.
Clinical Complete Slippage Rate
Time frame: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No. If the participants enroll in this study, study staff will collect personal information about the participants. Study staff will protect information about participants and participant participation in this research study to the best of study staff ability. Study staff will assign participants a study number that study staff will use on all data collection forms in place of participants' names. Participant initials and date of birth may also be used on study forms to identify participants. If the results of this research are published, participants' names will not be shown. Study staff will follow institutional procedures for protecting privacy and promoting security during office, curbside exchange and videoconference visits.
Related trials for Contraceptive
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
RecruitingObservational study
Postprandial Glucose Handing in Contraceptive and IUD Users
Glucose Homeostasis
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.
Terri Walsh, MPH principal investigator
Essential Access Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Product in people with Contraceptive and Sexually Transmitted Diseases, run by Church & Dwight Company, Inc. at 2 sites 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 13 inclusion and 9 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: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Clinical Failure Rate (time frame: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.). 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 8 Nov 2023.