Contraception, Prevention of Sexually Transmitted Infections
Conditions
Brief summary
The clinical study will compare two lubricated polyurethane male condoms of different thickness with a marketed lubricated control male condom made of natural rubber latex. This crossover study will randomize 300 heterosexual couples to the sequence in which they use five condoms of each of the three study condom types. The clinical failure (breakage and slippage) rates of the two polyurethane condoms will be compared to the clinical failure (breakage and slippage) rate of commercial natural rubber latex control condom using a statistical test of non-inferiority. The study will also compare the acceptability of the two polyurethane condom different thickness with that of the natural rubber latex control condom obtained from interviews and questionnaires with subject couples.
Detailed description
The clinical study will compare two lubricated polyurethane male condoms of different thickness and different sizes with a marketed lubricated control male condom made of natural rubber latex. Couples entering the study will be expected to use 5 of each type of the 3 condoms in a randomised order. The identity of the condoms will be masked to both the couples and the investigators. The aim will be to recruit 300 heterosexual with the intent of achieving a minimum 1,000 uses of each condom type. Couples will report condom use events using a condom report form. The primary information collected will relate to condom breakage and slippage of the penis during use. The total clinical failure rates (breakage and slippage) of the two polyurethane condoms will be compared to the clinical failure (breakage and slippage) rate of commercial natural rubber latex control condom using a statistical test of non-inferiority. The study will also compare the acceptability of the two polyurethane condom different thickness with that of the natural rubber latex control condom obtained from interviews and questionnaires with subject couples.
Interventions
DEVICEControl Latex Condom C, Polyurethane Condom A, Polyurethane Condom B
Condom functionality study to determine failure rates
Sponsors
Essential Access Health
Sagami Rubber Industries Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Between the ages of 18 and 45 (inclusive) 2. Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy) 3. Have home internet access, a valid personal email for each partner, ability to videoconference and use electronic signature technology 4. Willing and able to give electronic informed consent 5. Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms via interview or self-administered questionnaires 6. Have vaginal intercourse at least once weekly 7. Willing to use the study products for fifteen acts of vaginal intercourse within nine weeks of study entry 8. In a mutually exclusive monogamous relationship with their study partner for at least 6 months and be willing to remain mutually monogamous throughout study participation 9. Both study partners have previous experience using male condoms 10. Agree not to use any additional vaginal or sexual lubricant except the AstroglideTM product provided, if desired, supplied by the study 11. Agree not to expose the study condoms to jewelry (hand, facial, or genital) or piercings (facial or genital) that could damage the study condoms. 12. Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms 13. Male partner agrees to ejaculate during vaginal intercourse 14. Agree to (or partner) hold the condom at the base of the erect penis during withdrawal 15. Agree to return any condoms that break during use 16. Agree to return any unopened condoms 17. Reachable by telephone
Exclusion criteria
1. Currently participating in another similar clinical study 2. Female partner self-reported as pregnant 3. Allergic to natural rubber latex or polyurethane, or has a history of recurrent adverse events following use of latex or polyurethane products 4. Unable to follow study requirements, use instructions or attend study visits or exchanges 5. Have a significant (high) risk of STIs, including HIV infection, or having a medical history of recurrent, uncontrolled STIs (e.g. gonorrhoea, syphilis, Chlamydia, etc.) 6. Currently using condoms for protection against a known STI 7. Taking any internally applied medication to treat a genital condition that could interact with the study condom 8. Male partner has used medication that has caused erectile dysfunction, or had difficulty achieving/maintaining an erection, or achieving ejaculation in the last month under typical circumstances/conditions 9. Male has had a prostatectomy 10. Any self-reported genitourinary 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 11. Employee or affiliate of Essential Access Health or Sagami Rubber Industries Co., Ltd.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Self Completion of Questionnaires Within 12 Hours of condom use. Questionnaires returned to investigators when receiving next set of 5 condoms. All sets of questionnaires returned within 9 weeks of couple starting. | To confirm each experimental condom is non-inferior to the control condom with respect to total clinical failure rate. The definition of total clinical failure rate as specified in ISO 29943-1:2017 will be used. The Total Clinical Failure Rate is Defined as the Number of Condoms with at least One Acute Failure Event (e.g. Clinical Breakage or Clinical Slippage) Divided by the Number of Condoms Used During Intercourse; Typically Reported as a Percentage; Any Condom which Experiences Multiple Clinical Failure Events Only Count as a Single Clinical Failure. To be eligible for inclusion in the non-inferiority analysis the each couple had to have used at least one of the appropriate experimental condoms and at least one control condom. This means that the numbers of participants and condoms reported in each of the two non-inferiority comparisons will differ. |
Countries
United States
Participant flow
Recruitment details
The total recruitment target was 300 couples consented couples (600 participants). Each couple to participate in each of the 6 arms using 5 condoms of each type in a randomized block sequence. The six randomized sequences were ABC, ACB, BAC, BCA, CAB, CBA. Each couple received 5 of the first assigned condom at the start of the study along with a set of 5 blank condom reports. Couples also received a penis measuring kit. The couples were expected to use all 15 condoms within 9 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Population The total number of couples consented was 300 (600 participants). These were randomly assigned to the 6 arms of the study. | 600 |
| Total | 600 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Couples Used First Assigned Condom Set | Withdrawal by Subject | 2 | 2 | 0 | 0 | 2 | 5 |
| Couples Used Third Assigned Condom Set | Withdrawal by Subject | 0 | 0 | 2 | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall Study Population |
|---|---|
| Age, Categorical Female <=18 years | 0 Participants |
| Age, Categorical Female >=65 years | 0 Participants |
| Age, Categorical Female Between 18 and 65 years | 300 Participants |
| Age, Categorical Male <=18 years | 0 Participants |
| Age, Categorical Male >=65 years | 0 Participants |
| Age, Categorical Male Between 18 and 65 years | 300 Participants |
| Ethnicity (NIH/OMB) Number recruited Hispanic or Latino | 144 Participants |
| Ethnicity (NIH/OMB) Number recruited Not Hispanic or Latino | 456 Participants |
| Ethnicity (NIH/OMB) Number recruited Unknown or Not Reported | 0 Participants |
| Number of participants completing study as per protocol | 568 Participants |
| Region of Enrollment United States | 600 participants |
| Sex: Female, Male Female | 300 Participants |
| Sex: Female, Male Male | 300 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 337 | 0 / 392 | 0 / 332 |
| other Total, other adverse events | 41 / 337 | 85 / 392 | 87 / 332 |
| serious Total, serious adverse events | 4 / 337 | 10 / 392 | 20 / 332 |
Outcome results
Primary
Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017.
To confirm each experimental condom is non-inferior to the control condom with respect to total clinical failure rate. The definition of total clinical failure rate as specified in ISO 29943-1:2017 will be used. The Total Clinical Failure Rate is Defined as the Number of Condoms with at least One Acute Failure Event (e.g. Clinical Breakage or Clinical Slippage) Divided by the Number of Condoms Used During Intercourse; Typically Reported as a Percentage; Any Condom which Experiences Multiple Clinical Failure Events Only Count as a Single Clinical Failure. To be eligible for inclusion in the non-inferiority analysis the each couple had to have used at least one of the appropriate experimental condoms and at least one control condom. This means that the numbers of participants and condoms reported in each of the two non-inferiority comparisons will differ.
Time frame: Self Completion of Questionnaires Within 12 Hours of condom use. Questionnaires returned to investigators when receiving next set of 5 condoms. All sets of questionnaires returned within 9 weeks of couple starting.
Population: The number of participants and condoms used for the non-inferiority assessment of Condom A versus Condom C and the equivalent numbers in the non-inferiority assessment of Condom B versus Condom C differ because some men found Condom B to be too small to use.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Polyurethane Condoms A Used in Non-inferiority Analysis Condom A of Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Primary Analysis of Study Data | Clinical Breaks | 15 Condom uses |
| Polyurethane Condoms A Used in Non-inferiority Analysis Condom A of Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. | Clinical slippages | 0 Condom uses |
| Polyurethane Condoms A Used in Non-inferiority Analysis Condom A of Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Primary Analysis of Study Data | Clinical slippages | 13 Condom uses |
| Polyurethane Condoms A Used in Non-inferiority Analysis Condom A of Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Primary Analysis of Study Data | Successful Uses | 1165 Condom uses |
| Polyurethane Condoms A Used in Non-inferiority Analysis Condom A of Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. | Successful Uses | 0 Condom uses |
| Polyurethane Condoms A Used in Non-inferiority Analysis Condom A of Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. | Clinical Breaks | 0 Condom uses |
| Latex Condoms C Used in Non-inferiority Analysis of Condom A Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. | Clinical Breaks | 0 Condom uses |
| Latex Condoms C Used in Non-inferiority Analysis of Condom A Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. | Clinical slippages | 0 Condom uses |
| Latex Condoms C Used in Non-inferiority Analysis of Condom A Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Primary Analysis of Study Data | Successful Uses | 1196 Condom uses |
| Latex Condoms C Used in Non-inferiority Analysis of Condom A Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. | Successful Uses | 0 Condom uses |
| Latex Condoms C Used in Non-inferiority Analysis of Condom A Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Primary Analysis of Study Data | Clinical slippages | 6 Condom uses |
| Latex Condoms C Used in Non-inferiority Analysis of Condom A Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Primary Analysis of Study Data | Clinical Breaks | 10 Condom uses |
| Polyurethane Condoms B Used in Non-inferiority Analysis of Condom B Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. | Clinical Breaks | 12 Condom uses |
| Polyurethane Condoms B Used in Non-inferiority Analysis of Condom B Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Primary Analysis of Study Data | Clinical slippages | 13 Condom uses |
| Polyurethane Condoms B Used in Non-inferiority Analysis of Condom B Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Primary Analysis of Study Data | Successful Uses | 1107 Condom uses |
| Polyurethane Condoms B Used in Non-inferiority Analysis of Condom B Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. | Clinical slippages | 8 Condom uses |
| Polyurethane Condoms B Used in Non-inferiority Analysis of Condom B Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. | Successful Uses | 866 Condom uses |
| Polyurethane Condoms B Used in Non-inferiority Analysis of Condom B Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Primary Analysis of Study Data | Clinical Breaks | 22 Condom uses |
| Latex Condom C Used in Non-inferiority Analysis of Condom B Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Primary Analysis of Study Data | Successful Uses | 1178 Condom uses |
| Latex Condom C Used in Non-inferiority Analysis of Condom B Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Primary Analysis of Study Data | Clinical Breaks | 9 Condom uses |
| Latex Condom C Used in Non-inferiority Analysis of Condom B Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Primary Analysis of Study Data | Clinical slippages | 6 Condom uses |
| Latex Condom C Used in Non-inferiority Analysis of Condom B Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. | Clinical Breaks | 5 Condom uses |
| Latex Condom C Used in Non-inferiority Analysis of Condom B Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. | Successful Uses | 904 Condom uses |
| Latex Condom C Used in Non-inferiority Analysis of Condom B Versus Condom C | Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. | Clinical slippages | 6 Condom uses |
Comparison: Null Hypothesis: Expected test condom total clinical failure rate - expected control natural rubber latex male condom total clinical failure rate ≥ δ, where δ = 2.5%; Power calculations were conducted according to ISO 29943-1:2017. Target sample sizes were chosen to provide a power of at least 90%.p-value: 0.025GEE
Comparison: Null Hypothesis: Test condom total clinical failure rate - control natural rubber latex male condom total clinical failure rate ≥ δ, where δ = 2.5%; Power calculations were conducted according to ISO 29943-1:2017. Target sample sizes were chosen to provide a power of at least 90%.p-value: 0.025GEE
Comparison: The non-inferiority analysis was repeated after removing couples where the male partner had a penis length greater than 170 mm. The polyurethane condom B has a specified nominal length of 170 mm and is not recommended for men with penises longer than the length of the condom.p-value: 0.025GEE