Microbicide Delivery System Acceptability
Conditions
Keywords
topical microbicide, primary prevention, HIV, drug delivery systems
Brief summary
The purpose of the study is to compare, contrast, and characterize the range of user perceptions and potential acceptability of three (3) topical vaginal microbicide dosage forms.
Detailed description
The success of microbicide products will derive from the synergy of their biological functionality and user acceptability. Biological functionality is the integrated result of safe and effective anti-HIV compounds incorporated into dosage forms or devices that successfully deliver those compounds to target tissues, fluids, and pathogens. Acceptability is a multi-factorial phenomenon that accounts for the personal, dyadic, product-related, and social contexts that potentiate - or not - a woman's decision to use a microbicide. Acceptability (assessed, in part, by the users' sensory perceptions of products during use) depends strongly upon dosage forms and/or delivery systems with biophysical functions and/or mechanical and materials properties that are most conducive to human use. Without both, microbicides' potential to decisively alter the public health impact of HIV/AIDS and other sexually transmitted infections will be largely limited. The current protocol will specifically study the impact of gel volume on user perceptions, as well as extend user perception scale development to include those properties and product behaviors experienced when using a vaginal film.
Interventions
OTHERhigh volume gel
4 mL HEC
OTHERlow volume gel
2 mL HEC
OTHERvaginal film
1 x 2 intravaginal quick-dissolving film
Sponsors
ImQuest Pharmaceuticals, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
The Miriam Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Mixed Methods Measurement Development study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Women who: * are between the ages of 18 and 45 * report vaginal sex with their male sexual partner in the past 6 months * report being in a monogamous sexual relationship with their male partner * report consistent use of an effective birth control method: e.g., hormonal contraceptive, IUD, bilateral tubal ligation, Essure® or any non-incisional permanent birth control procedure, hysterectomy (partial or total, with/without oophorectomy), partner's vasectomy/salpingectomy * are able to tolerate film use, as measured by pelvic exam at Visit 1B * are willing to refrain from any vaginal product use (inclusive of douching) for 48 hours before Visit 1B and until they complete all study activities (except for study-related products) * are willing to refrain from having vaginal intercourse 24 hours before Visit 1B and Visits 2-4 * are willing to use condoms for vaginal-penile sex between all study visits (Visits 1A - 4) * are willing to refrain from any non-penile vaginal penetration during dosage form evaluation visits (Visits 2-4) * are willing to undergo HIV testing and receive test results and counseling. Men who: * are at least 18 years of age * report vaginal sex with their female sexual partner in the past 6 months * report being in a monogamous sexual relationship with their female sexual partner * are willing to refrain from having vaginal intercourse 24 hours before Visit 1B and Visits 2-4 * are willing to use condoms for vaginal-penile sex between all of study visits (Visits 1A-4) * are willing to refrain from any non-penile vaginal penetration during dosage form evaluation visits (Visits 2-4) * are willing to use a non-lubricated latex condom (provided) for penile-vaginal intercourse during dosage form evaluation visits (Visits 2-4) * are willing to undergo HIV testing and receive test results and counseling.
Exclusion criteria
Women and men will be ineligible if: * they are unable or unwilling to give informed consent * their partner is unable or unwilling to give informed consent * they are currently enrolled in other vaginal product study/studies * they are STI (Neisseria gonorrhea, Chlamydia trachomatis, bacterial vaginosis, trichomoniasis, syphilis), HIV positive upon screening (Visit 1A), or pregnant (females) at any study visit * they are breastfeeding, or have completed menopause (i.e., at least 12 months without menstrual periods) (female participants only) * they are currently attempting to get pregnant or have an intention to get pregnant during their participation in the study * they have clinically significant abnormal pelvic findings and/or findings requiring therapy as a function of clinical exam at Visits 1A and/or 1B (female participants only) * they report being within 30 days of their last pregnancy outcome or gynecologic surgical procedure * they have known, or suspected, allergies to any component of the study products or similar ingredients in other products * they have known, or suspected, allergies to latex * they have any condition that, in the opinion of the study clinician or principle investigator, would compromise the participant´s ability to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | 4-5 visits over an average of 8-12 weeks | USPE Sum of averaged item means/# items (min:max 1:5); 1=Do not agree at all;2=Agree a little;3=Agree somewhat;4=Agree a lot;5=Agree completely. Products:Low volume gel, high volume gel, film.Initial Penetration:Smoothness/lubricity; Initial Lubrication:Coating/lubricating; Spreading Behavior:Ease of stroke, product spread; Product Awareness:Feel intravaginally during sex (movement, felt betw vaginal wall-penis); Perceived Wetness:Covering entire vagina; as after orgasm; Stimulating: enhanced pleasure; Messiness:Perceptions of watery/messiness; Leakage:Sensations of leaking during/after sex; in pubic hair; need to clean; Pre-coital Leakage:Product felt/leakage noticed on panty liner before sex; Naturalness:Sensation of naturalness; leakage looked like vaginal fluid; Lubricity:Wetness before sex; slipperiness/lubricity during sex; Effortful:Effort needed at penetration; effort difficulty/dryness; Pleasure:Partner's stimulation; Noticeable:Male sensation during sex, messiness, thickness |
Countries
United States
Participant flow
Recruitment details
Recruited (RI, MA USA) via call-lists, flyers, ads, internet/social media, clinics, CBOs, word-of-mouth.
Participants by arm
| Arm | Count |
|---|---|
| Female Member of Couple Enrolled Heterosexual mutually monogamous couples in good general health evaluate 3 topical vaginal formulations (all placebo) | 24 |
| Male Member of Couple Enrolled Heterosexual mutually monogamous couples in good general health evaluate 3 topical vaginal formulations (all placebo) | 24 |
| Total | 48 |
Baseline characteristics
| Characteristic | Female Member of Couple Enrolled | Male Member of Couple Enrolled | Total |
|---|---|---|---|
| Age, Customized 18-29 | 12 Participants | 12 Participants | 24 Participants |
| Age, Customized 30+ | 12 Participants | 12 Participants | 24 Participants |
| Current Contraceptive Use Hormonal Contraceptive | 17 Participants | — | 17 Participants |
| Current Contraceptive Use Non-Hormonal Contraceptive | 7 Participants | — | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 22 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| History of STD diagnosis | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 15 Participants | 17 Participants | 32 Participants |
| Region of Enrollment United States | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Female | 24 Participants | 0 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 24 Participants | 24 Participants |
| Vaginal Deliveries | 9 Participants | — | 9 Participants |
| Yearly Income $15,000-$36,000 annually | 7 Participants | 10 Participants | 17 Participants |
| Yearly Income Less than $15,000 annually | 12 Participants | 6 Participants | 18 Participants |
| Yearly Income More than $36,000 annually | 5 Participants | 8 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 6 / 24 | 1 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
Primary
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
USPE Sum of averaged item means/# items (min:max 1:5); 1=Do not agree at all;2=Agree a little;3=Agree somewhat;4=Agree a lot;5=Agree completely. Products:Low volume gel, high volume gel, film.Initial Penetration:Smoothness/lubricity; Initial Lubrication:Coating/lubricating; Spreading Behavior:Ease of stroke, product spread; Product Awareness:Feel intravaginally during sex (movement, felt betw vaginal wall-penis); Perceived Wetness:Covering entire vagina; as after orgasm; Stimulating: enhanced pleasure; Messiness:Perceptions of watery/messiness; Leakage:Sensations of leaking during/after sex; in pubic hair; need to clean; Pre-coital Leakage:Product felt/leakage noticed on panty liner before sex; Naturalness:Sensation of naturalness; leakage looked like vaginal fluid; Lubricity:Wetness before sex; slipperiness/lubricity during sex; Effortful:Effort needed at penetration; effort difficulty/dryness; Pleasure:Partner's stimulation; Noticeable:Male sensation during sex, messiness, thickness
Time frame: 4-5 visits over an average of 8-12 weeks
Population: Perceived Pre-Sex Leakage not applicable for Male members of enrolled couples
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Initial Penetration [High Volume Gel] | 4.35 units on a scale | Standard Deviation 0.76 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Initial Lubrication [High Volume Gel] | 3.89 units on a scale | Standard Deviation 1.02 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Initial Penetration [Low Volume Gel] | 3.64 units on a scale | Standard Deviation 1.2 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Initial Penetration [Film] | 1.74 units on a scale | Standard Deviation 1.16 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Initial Lubrication [Low Volume Gel] | 3.54 units on a scale | Standard Deviation 1.22 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Initial Lubrication [Film] | 2.55 units on a scale | Standard Deviation 1.27 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Product Awareness [Low Volume Gel] | 2.55 units on a scale | Standard Deviation 0.94 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Product Awareness [High Volume Gel] | 2.89 units on a scale | Standard Deviation 1.1 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Product Awareness [Film] | 1.73 units on a scale | Standard Deviation 0.68 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Wetness [Low Volume Gel] | 2.88 units on a scale | Standard Deviation 1.33 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Wetness [High Volume Gel] | 3.43 units on a scale | Standard Deviation 0.95 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Wetness [Film] | 1.74 units on a scale | Standard Deviation 0.85 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Stimulating [Low Volume Gel] | 2.35 units on a scale | Standard Deviation 1.05 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Stimulating [High Volume Gel] | 2.72 units on a scale | Standard Deviation 0.85 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Stimulating [Film] | 1.36 units on a scale | Standard Deviation 0.73 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Messiness [Low Volume Gel] | 1.65 units on a scale | Standard Deviation 0.69 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Messiness [High Volume Gel] | 2.11 units on a scale | Standard Deviation 0.81 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Messiness [Film] | 1.39 units on a scale | Standard Deviation 0.49 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Leakage [Low Volume Gel] | 2.05 units on a scale | Standard Deviation 0.89 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Leakage [High Volume Gel] | 2.44 units on a scale | Standard Deviation 0.95 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Leakage [Film] | 1.48 units on a scale | Standard Deviation 0.62 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Naturalness [Low Volume Gel] | 3.38 units on a scale | Standard Deviation 0.81 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Naturalness [High Volume Gel] | 3.44 units on a scale | Standard Deviation 0.93 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Naturalness [Film] | 2.40 units on a scale | Standard Deviation 1.23 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Lubricity [Low Volume Gel] | 3.10 units on a scale | Standard Deviation 1.2 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Lubricity [High Volume Gel] | 3.50 units on a scale | Standard Deviation 1.08 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Lubricity [Film] | 1.38 units on a scale | Standard Deviation 0.63 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Effortful [Low Volume Gel] | 1.41 units on a scale | Standard Deviation 0.59 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Effortful [High Volume Gel] | 1.17 units on a scale | Standard Deviation 0.46 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Effortful [Film] | 3.08 units on a scale | Standard Deviation 1.53 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Pleasure [Low Volume Gel] | 2.35 units on a scale | Standard Deviation 0.97 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Pleasure [High Volume Gel] | 2.93 units on a scale | Standard Deviation 1.04 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Pleasure [Film] | 1.43 units on a scale | Standard Deviation 0.87 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Pre-Sex Leakage [Low Volume Gel] | 2.08 units on a scale | Standard Deviation 1.34 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Pre-Sex Leakage [High Volume Gel] | 2.89 units on a scale | Standard Deviation 1.49 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Pre-Sex Leakage [Film] | 1.25 units on a scale | Standard Deviation 0.72 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Noticeable [Low Volume Gel] | 2.14 units on a scale | Standard Deviation 1 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Noticeable [High Volume Gel] | 2.65 units on a scale | Standard Deviation 1.29 |
| Female Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Noticeable [Film] | 1.75 units on a scale | Standard Deviation 1.19 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Initial Penetration [Low Volume Gel] | 3.86 units on a scale | Standard Deviation 0.75 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Initial Penetration [High Volume Gel] | 3.83 units on a scale | Standard Deviation 0.74 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Leakage [High Volume Gel] | 2.10 units on a scale | Standard Deviation 0.77 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Initial Penetration [Film] | 2.06 units on a scale | Standard Deviation 1.03 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Noticeable [Film] | 1.78 units on a scale | Standard Deviation 0.78 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Initial Lubrication [Low Volume Gel] | 3.58 units on a scale | Standard Deviation 0.72 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Initial Lubrication [High Volume Gel] | 3.78 units on a scale | Standard Deviation 0.77 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Leakage [Film] | 1.38 units on a scale | Standard Deviation 0.45 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Initial Lubrication [Film] | 2.60 units on a scale | Standard Deviation 1.04 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Effortful [High Volume Gel] | 1.19 units on a scale | Standard Deviation 0.47 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Product Awareness [Low Volume Gel] | 2.72 units on a scale | Standard Deviation 0.95 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Naturalness [Low Volume Gel] | 3.17 units on a scale | Standard Deviation 0.95 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Product Awareness [High Volume Gel] | 3.10 units on a scale | Standard Deviation 1.16 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Pleasure [Film] | 2.08 units on a scale | Standard Deviation 0.9 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Product Awareness [Film] | 2.04 units on a scale | Standard Deviation 0.88 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Naturalness [High Volume Gel] | 3.17 units on a scale | Standard Deviation 0.97 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Wetness [Low Volume Gel] | 3.00 units on a scale | Standard Deviation 0.91 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Effortful [Film] | 2.81 units on a scale | Standard Deviation 1.26 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Wetness [High Volume Gel] | 3.38 units on a scale | Standard Deviation 1.04 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Naturalness [Film] | 2.60 units on a scale | Standard Deviation 1.42 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Wetness [Film] | 1.94 units on a scale | Standard Deviation 0.86 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Noticeable [High Volume Gel] | 2.89 units on a scale | Standard Deviation 1.07 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Stimulating [Low Volume Gel] | 2.58 units on a scale | Standard Deviation 1.04 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Lubricity [Low Volume Gel] | 3.15 units on a scale | Standard Deviation 1.1 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Stimulating [High Volume Gel] | 2.66 units on a scale | Standard Deviation 0.98 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Pleasure [Low Volume Gel] | 2.88 units on a scale | Standard Deviation 0.82 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Stimulating [Film] | 1.99 units on a scale | Standard Deviation 0.92 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Lubricity [High Volume Gel] | 3.42 units on a scale | Standard Deviation 1.05 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Messiness [Low Volume Gel] | 1.84 units on a scale | Standard Deviation 0.7 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Noticeable [Low Volume Gel] | 2.54 units on a scale | Standard Deviation 1.01 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Messiness [High Volume Gel] | 2.18 units on a scale | Standard Deviation 0.8 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Lubricity [Film] | 1.63 units on a scale | Standard Deviation 0.8 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Messiness [Film] | 1.32 units on a scale | Standard Deviation 0.33 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Pleasure [High Volume Gel] | 2.92 units on a scale | Standard Deviation 1 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Perceived Leakage [Low Volume Gel] | 1.73 units on a scale | Standard Deviation 0.57 |
| Male Members | User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | SEX: Effortful [Low Volume Gel] | 1.53 units on a scale | Standard Deviation 0.76 |