Vulvodynia, Dyspareunia, Breast Cancer, Menopause
Conditions
Keywords
Vulvodynia, Dyspareunia, Breast Cancer, Menopause, Vaginal dryness, Painful intercourse
Brief summary
The purpose of this protocol is to determine whether pain with sexual intercourse can be reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain. The investigators hypothesize that the pain arises in the vulvar vestibule. The investigators predict that the localized use of lidocaine will be more efficacious than use of placebo liquid.
Detailed description
For this study there will be three visits over a 3 month period. Subjects will undergo a gynecological exam at the screening visit to determine the severity of pain associated with uncomfortable intercourse. A touch test using Q-tips will be used during screening exam so subjects can report pain during application of both study drug and placebo. Subjects will also report pain during tampon test. A sample of vaginal cells and liquid will be obtained at screening visit so that PI can rule out possible infection, disease, or disorders. PI will also show subject the area of the vestibule in a mirror so that subject can apply study drug at home properly. Subjects will fill out 4 questionnaires about medical and health history, cancer history, pain, and distress and sexual activity. Subject will be given a supply of either study drug or placebo to take home. The first visit will last approximately 2 hours. Subjects will return for a second visit after 4 weeks and a third visit after 8 weeks for diary review, questionnaires, and examination. The second and third visit examinations will be repeats of the examination done at the first visit, but there will be no comparison with placebo, the PI will use only study drug during the touch test. The second and third visits will last approximately 1 hour. Subjects will fill out questionnaires throughout study participation. Topics include; medical and health history, cancer history, pain, distress and sexual activity. Subjects will also fill out a diary that charts tampon test completed from home, sexual activity performed, pain levels and study drug application days.
Interventions
DRUGTopical liquid lidocaine
active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule
DRUGTopical saline
saline applied to the vestibule mucosa will not reverse the local tenderness
Sponsors
OHSU Knight Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria 1. Women aged 18 to 70 years old. 2. Has a previous diagnosis of breast cancer (ductal or lobular carcinoma, invasive). 3. 1 year from diagnosis of breast cancer. 4. Stable heterosexual partnership =/\>5 years or by investigator discretion. 5. More than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain). 6. Menopausal, demonstrated by at least one of the following: i. cessation of menses for 1 years ii. Bilateral oophorectomy iii. Follicle Stimulating Hormone (FSH) level \>25 in women below age 50 with an ovary and scarred or absent uterus (acceptable FSH levels can be inferred if the woman's oncologist monitors FSH during aromatase inhibitor therapy). 7. Willingness to enter a study comparing a topical placebo liquid to topical liquid lidocaine. 8. Willingness to evaluate the liquids by use of a tampon test as many as 4 times per month, and willingness to attempt intercourse if the tampon test indicates tolerable penetrative pain. 3.2
Exclusion criteria
1. Diagnosis of benign or malignant phyllodes tumor of the breast. 2. Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia). 3. Has developed shrinkage of the vaginal opening or vaginal length to the point of being too small to succeed in having vaginal penetration with the partner (will also be assessed at the clinical exam). 4. Partner has a problem of sexual dysfunction limiting his performance or making it inconsistent. 5. The potential subject or her partner has a serious current medical condition that might interrupt completion of a 6 month study. 6. Potential subject has been diagnosed by a physical therapist with significant pelvic floor muscle dysfunction causing pain (pelvic floor myalgia). 7. Potential subject has used topical or systemic estrogen within the last 4 months. 8. Has continued tenderness of vestibule mucosa immediately after application of both test liquids. 9. Allergy to lidocaine or other numbing agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of Entry Dyspareunia With Non-hormonal Therapy | During Phase II (0-4 weeks) and during Phase III (5-12 weeks) | Mean intercourse pain reported by subjects using the Numerical Rating Scale pain ratings (range 0-10, 0 being no pain and 10 being worst possible pain). Testing was during weeks 0-4 (Phase II) (with blinded randomization for placebo vs active intervention medication) and testing was during weeks 5-12 (Phase III) (with open-label active medication for 8 weeks after completing the blinded 4 weeks). Subjects agreed to try penetration twice per week and score their pain using the Numerical Rating Scale pain ratings.The scores were averaged during each phase. |
| Location of Pain in Postmenopausal Dyspareunia | Enrollment visit | To determine the specific site of vulvovaginal tenderness in menopausal breast cancer survivors who have entry dyspareunia. Examine the vulvar vestibule with a swab test to determine locations and severity of touch tenderness. Eight sites were evaluated around the vaginal opening and there location was in reference to a clock face. Measured using the Numerical Rating Scale, a scale which measures pain from 0 to 10 with 0=no pain and 10=the worst pain you have ever felt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Quality of Sexual Life - Visit 1 | Visit 1 (Enrollment) | To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function). |
| Improvement of Quality of Sexual Life - Visit 2 | Visit 2 (Week 4) | To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by averaged scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function). |
| Improvement of Quality of Sexual Life - Visit 3 | Visit 3 (End of Study) | To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function). |
Countries
United States
Participant flow
Recruitment details
January 2012 to June 2013; Women's Health Research Unit (WHRU) at Oregon Health and Science University (OHSU) in Portland, OR
Participants by arm
| Arm | Count |
|---|---|
| Topical Liquid Lidocaine Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule | 25 |
| Topical Saline Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Screening Error. Deleted from analysis. | 1 | 0 |
Baseline characteristics
| Characteristic | Topical Liquid Lidocaine | Topical Saline | Total |
|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 8.5 | 54.7 years STANDARD_DEVIATION 8.9 | 55.34 years STANDARD_DEVIATION 8.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 25 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 22 Participants | 44 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex/Gender, Customized Female | 25 participants | 25 participants | 50 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Location of Pain in Postmenopausal Dyspareunia
To determine the specific site of vulvovaginal tenderness in menopausal breast cancer survivors who have entry dyspareunia. Examine the vulvar vestibule with a swab test to determine locations and severity of touch tenderness. Eight sites were evaluated around the vaginal opening and there location was in reference to a clock face. Measured using the Numerical Rating Scale, a scale which measures pain from 0 to 10 with 0=no pain and 10=the worst pain you have ever felt.
Time frame: Enrollment visit
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Topical Saline | Location of Pain in Postmenopausal Dyspareunia | 3 o'clock | 3 units on a scale from 0 to 10 |
| Topical Saline | Location of Pain in Postmenopausal Dyspareunia | 1 o'clock | 0 units on a scale from 0 to 10 |
| Topical Saline | Location of Pain in Postmenopausal Dyspareunia | 11 o'clock | 0 units on a scale from 0 to 10 |
| Topical Saline | Location of Pain in Postmenopausal Dyspareunia | 12 o'clock | 1 units on a scale from 0 to 10 |
| Topical Saline | Location of Pain in Postmenopausal Dyspareunia | 4 o'clock | 4 units on a scale from 0 to 10 |
| Topical Saline | Location of Pain in Postmenopausal Dyspareunia | 8 o'clock | 4 units on a scale from 0 to 10 |
| Topical Saline | Location of Pain in Postmenopausal Dyspareunia | 9 o'clock | 5 units on a scale from 0 to 10 |
| Topical Saline | Location of Pain in Postmenopausal Dyspareunia | 6 o'clock | 2 units on a scale from 0 to 10 |
| Topical Liquid Lidocaine | Location of Pain in Postmenopausal Dyspareunia | 6 o'clock | 0 units on a scale from 0 to 10 |
| Topical Liquid Lidocaine | Location of Pain in Postmenopausal Dyspareunia | 4 o'clock | 0 units on a scale from 0 to 10 |
| Topical Liquid Lidocaine | Location of Pain in Postmenopausal Dyspareunia | 1 o'clock | 0 units on a scale from 0 to 10 |
| Topical Liquid Lidocaine | Location of Pain in Postmenopausal Dyspareunia | 9 o'clock | 0 units on a scale from 0 to 10 |
| Topical Liquid Lidocaine | Location of Pain in Postmenopausal Dyspareunia | 11 o'clock | 0 units on a scale from 0 to 10 |
| Topical Liquid Lidocaine | Location of Pain in Postmenopausal Dyspareunia | 8 o'clock | 0 units on a scale from 0 to 10 |
| Topical Liquid Lidocaine | Location of Pain in Postmenopausal Dyspareunia | 12 o'clock | 0 units on a scale from 0 to 10 |
| Topical Liquid Lidocaine | Location of Pain in Postmenopausal Dyspareunia | 3 o'clock | 0 units on a scale from 0 to 10 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Primary
Prevention of Entry Dyspareunia With Non-hormonal Therapy
Mean intercourse pain reported by subjects using the Numerical Rating Scale pain ratings (range 0-10, 0 being no pain and 10 being worst possible pain). Testing was during weeks 0-4 (Phase II) (with blinded randomization for placebo vs active intervention medication) and testing was during weeks 5-12 (Phase III) (with open-label active medication for 8 weeks after completing the blinded 4 weeks). Subjects agreed to try penetration twice per week and score their pain using the Numerical Rating Scale pain ratings.The scores were averaged during each phase.
Time frame: During Phase II (0-4 weeks) and during Phase III (5-12 weeks)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Topical Saline | Prevention of Entry Dyspareunia With Non-hormonal Therapy | Phase II | 5.3 Units on a scale |
| Topical Saline | Prevention of Entry Dyspareunia With Non-hormonal Therapy | Phase III | 0.57 Units on a scale |
| Topical Liquid Lidocaine | Prevention of Entry Dyspareunia With Non-hormonal Therapy | Phase II | 1.04 Units on a scale |
| Topical Liquid Lidocaine | Prevention of Entry Dyspareunia With Non-hormonal Therapy | Phase III | 0.45 Units on a scale |
| Open Label | Prevention of Entry Dyspareunia With Non-hormonal Therapy | Phase II | NA Units on a scale |
| Open Label | Prevention of Entry Dyspareunia With Non-hormonal Therapy | Phase III | 0.48 Units on a scale |
Comparison: Phase II: During Blinded 4 weeksp-value: 0.0149Wilcoxon (Mann-Whitney)
Comparison: Phase IIIp-value: 0.412Wilcoxon (Mann-Whitney)
Secondary
Improvement of Quality of Sexual Life - Visit 1
To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).
Time frame: Visit 1 (Enrollment)
Population: Averaged scores of Sexual Function Questionnaire Visit 1 each time scoring from the prior 30 days.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Topical Saline | Improvement of Quality of Sexual Life - Visit 1 | Orgasm | 5.70 units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 1 | Arousal Lubrication | 3.92 units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 1 | Pain | 6.04 units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 1 | Arousal Sensation | 8.44 units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 1 | Enjoyment | 15.30 units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 1 | Arousal Cognitive | 4.28 units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 1 | Partner | 7.78 units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 1 | Desire | 11.91 units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 1 | Partner | 8.13 units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 1 | Arousal Sensation | 9.15 units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 1 | Arousal Lubrication | 2.97 units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 1 | Arousal Cognitive | 4.82 units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 1 | Orgasm | 7.62 units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 1 | Pain | 6.29 units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 1 | Enjoyment | 17.01 units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 1 | Desire | 13.87 units on a scale |
Comparison: Desirep-value: 0.66Wilcoxon (Mann-Whitney)
Comparison: Arousal (S)p-value: 0.11Wilcoxon (Mann-Whitney)
Comparison: Arousal (L)p-value: 0.15Wilcoxon (Mann-Whitney)
Comparison: Arousal (C)p-value: 0.28Wilcoxon (Mann-Whitney)
Comparison: Orgasmp-value: 0.07Wilcoxon (Mann-Whitney)
Comparison: Painp-value: 0.004Wilcoxon (Mann-Whitney)
Comparison: Enjoymentp-value: 0.54Wilcoxon (Mann-Whitney)
Comparison: Partnerp-value: 0.92Wilcoxon (Mann-Whitney)
Secondary
Improvement of Quality of Sexual Life - Visit 2
To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by averaged scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).
Time frame: Visit 2 (Week 4)
Population: Averaged scores of Sexual Function Questionnaire at Visit 2 scoring from the prior 30 days.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Topical Saline | Improvement of Quality of Sexual Life - Visit 2 | Desire | 14 Units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 2 | Arousal Sensation | 8.14 Units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 2 | Arousal Lubrication | 3.59 Units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 2 | Arousal Cognitive | 4.69 Units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 2 | Orgasm | 5.07 Units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 2 | Pain | 7.96 Units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 2 | Enjoyment | 16.9 Units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 2 | Partner | 8.62 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 2 | Partner | 8.68 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 2 | Desire | 16.09 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 2 | Orgasm | 9.05 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 2 | Arousal Sensation | 11.21 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 2 | Enjoyment | 19.36 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 2 | Arousal Lubrication | 4.18 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 2 | Pain | 10.50 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 2 | Arousal Cognitive | 5.99 Units on a scale |
Secondary
Improvement of Quality of Sexual Life - Visit 3
To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).
Time frame: Visit 3 (End of Study)
Population: Averaged scores of Sexual Function Questionnaire at Visit 1 scoring from the prior 30 days.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Topical Saline | Improvement of Quality of Sexual Life - Visit 3 | Desire | 17.79 Units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 3 | Arousal Sensation | 10.89 Units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 3 | Arousal Lubrication | 4.79 Units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 3 | Arousal Cognitive | 5.74 Units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 3 | Orgasm | 6.95 Units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 3 | Pain | 11.18 Units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 3 | Enjoyment | 20.90 Units on a scale |
| Topical Saline | Improvement of Quality of Sexual Life - Visit 3 | Partner | 8.95 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 3 | Partner | 9.36 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 3 | Desire | 18.32 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 3 | Orgasm | 9.5 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 3 | Arousal Sensation | 13.15 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 3 | Enjoyment | 22.51 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 3 | Arousal Lubrication | 5.2 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 3 | Pain | 11.67 Units on a scale |
| Topical Liquid Lidocaine | Improvement of Quality of Sexual Life - Visit 3 | Arousal Cognitive | 7.05 Units on a scale |