N/A
Completed N=300
Evaluation of Polyurethane Male Condoms
Contraception · Prevention of Sexually Transmitted Infections
Source: ClinicalTrials.gov NCT04622306 ↗
Enrolled (actual)
300
Serious AEs
3.2%
Results posted
Jun 2023
Primary outcomePrimary: 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. — 15; 10; 22; 9 Condom uses — p=0.025
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
15; 10; 22; 9; 13; 6 | 0.025 sig |
Eligibility Criteria
Inclusion Criteria
- Between the ages of 18 and 45 (inclusive)
- Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
- Have home internet access, a valid personal email for each partner, ability to videoconference and use electronic signature technology
- Willing and able to give electronic informed consent
- Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms via interview or self-administered questionnaires
- Have vaginal intercourse at least once weekly
- Willing to use the study products for fifteen acts of vaginal intercourse within nine weeks of study entry
- 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
- Both study partners have previous experience using male condoms
- Agree not to use any additional vaginal or sexual lubricant except the AstroglideTM product provided, if desired, supplied by the study
- Agree not to expose the study condoms to jewelry (hand, facial, or genital) or piercings (facial or genital) that could damage the study condoms.
- Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms
- Male partner agrees to ejaculate during vaginal intercourse
- Agree to (or partner) hold the condom at the base of the erect penis during withdrawal
- Agree to return any condoms that break during use
- Agree to return any unopened condoms
- Reachable by telephone
Exclusion Criteria
- Currently participating in another similar clinical study
- Female partner self-reported as pregnant
- Allergic to natural rubber latex or polyurethane, or has a history of recurrent adverse events following use of latex or polyurethane products
- Unable to follow study requirements, use instructions or attend study visits or exchanges
- 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.)
- Currently using condoms for protection against a known STI
- Taking any internally applied medication to treat a genital condition that could interact with the study condom
- 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
- Male has had a prostatectomy
- 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
- Employee or affiliate of Essential Access Health or Sagami Rubber Industries Co., Ltd.
Data sourced from ClinicalTrials.gov (NCT04622306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.