Trials / Completed
CompletedNCT04622306
Evaluation of Polyurethane Male Condoms
A Randomized, Masked, 3-way Cross-over, Multi-center, Clinical Investigation to Evaluate Two Polyurethane Condoms in Healthy Monogamous Couples Compared With a Standard Latex Condom
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Sagami Rubber Industries Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B | Condom functionality study to determine failure rates |
Timeline
- Start date
- 2020-10-12
- Primary completion
- 2021-12-06
- Completion
- 2021-12-30
- First posted
- 2020-11-09
- Last updated
- 2023-10-06
- Results posted
- 2023-06-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04622306. Inclusion in this directory is not an endorsement.