Coitus
Conditions
Brief summary
The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.
Detailed description
Study to evaluate the safety of Class II personal lubricant devices.
Interventions
DEVICEPD-F-5254
Female Personal Lubricant (MINE)
DEVICE10855-096
Male Personal Lubricant (YOURS)
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Normal, healthy males and females \>18 years of age * In committed heterosexual relationship for \>6months * On acceptable method of birth control
Exclusion criteria
* Pregnant or breastfeeding * Allergy to product ingredients * Irritation or infection in genital area * Unstable or uncontrolled medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Showing Change From Baseline in Irritation Scores | 1 week | Number of participants showing change in irritation scores based on physical examinations of both male and female subjects according to a 6-point scale, ranging from 0=Normal appearance, no irritation to 6 = Presence of Lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Sensations Experienced by Male Subjects - Overall | 1 Week | Number of sensations experienced by male subjects, based on two applications of the investigational product. |
| Number of Sensations Experienced by Female Subjects - Overall | 1 Week | Number of sensations experienced by female subjects, based on two applications of the product for each subject. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study (ITT) The group evaluated was based on intention to treat (ITT). | 82 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Overall Study (ITT) |
|---|---|
| Age, Customized Female | 40.0 Years STANDARD_DEVIATION 13.3 |
| Age, Customized Male | 42.3 Years STANDARD_DEVIATION 14.5 |
| Region of Enrollment United States | 82 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 82 |
| serious Total, serious adverse events | 0 / 82 |
Outcome results
Primary
Number of Participants Showing Change From Baseline in Irritation Scores
Number of participants showing change in irritation scores based on physical examinations of both male and female subjects according to a 6-point scale, ranging from 0=Normal appearance, no irritation to 6 = Presence of Lesions
Time frame: 1 week
Population: Analysis was per Intention to Treat (ITT)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| MINE Alone | Number of Participants Showing Change From Baseline in Irritation Scores | 0 Participants | 0 |
| YOURS and MINE | Number of Participants Showing Change From Baseline in Irritation Scores | 0 Participants | 0 |
Secondary
Number of Sensations Experienced by Female Subjects - Overall
Number of sensations experienced by female subjects, based on two applications of the product for each subject.
Time frame: 1 Week
Population: Intention to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MINE Alone | Number of Sensations Experienced by Female Subjects - Overall | Burning | 4 Sensations |
| MINE Alone | Number of Sensations Experienced by Female Subjects - Overall | Tingling | 25 Sensations |
| MINE Alone | Number of Sensations Experienced by Female Subjects - Overall | Stinging | 4 Sensations |
| MINE Alone | Number of Sensations Experienced by Female Subjects - Overall | Warming | 31 Sensations |
| MINE Alone | Number of Sensations Experienced by Female Subjects - Overall | Itching | 1 Sensations |
| YOURS and MINE | Number of Sensations Experienced by Female Subjects - Overall | Warming | 22 Sensations |
| YOURS and MINE | Number of Sensations Experienced by Female Subjects - Overall | Itching | 0 Sensations |
| YOURS and MINE | Number of Sensations Experienced by Female Subjects - Overall | Burning | 6 Sensations |
| YOURS and MINE | Number of Sensations Experienced by Female Subjects - Overall | Stinging | 0 Sensations |
| YOURS and MINE | Number of Sensations Experienced by Female Subjects - Overall | Tingling | 22 Sensations |
Secondary
Number of Sensations Experienced by Male Subjects - Overall
Number of sensations experienced by male subjects, based on two applications of the investigational product.
Time frame: 1 Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MINE Alone | Number of Sensations Experienced by Male Subjects - Overall | Burning | 2 Sensations |
| MINE Alone | Number of Sensations Experienced by Male Subjects - Overall | Tingling | 16 Sensations |
| MINE Alone | Number of Sensations Experienced by Male Subjects - Overall | Stinging | 2 Sensations |
| MINE Alone | Number of Sensations Experienced by Male Subjects - Overall | Warming | 22 Sensations |
| MINE Alone | Number of Sensations Experienced by Male Subjects - Overall | Itching | 0 Sensations |
| YOURS and MINE | Number of Sensations Experienced by Male Subjects - Overall | Warming | 24 Sensations |
| YOURS and MINE | Number of Sensations Experienced by Male Subjects - Overall | Itching | 0 Sensations |
| YOURS and MINE | Number of Sensations Experienced by Male Subjects - Overall | Burning | 0 Sensations |
| YOURS and MINE | Number of Sensations Experienced by Male Subjects - Overall | Stinging | 3 Sensations |
| YOURS and MINE | Number of Sensations Experienced by Male Subjects - Overall | Tingling | 15 Sensations |