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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical liquid lidocaine | Active Comparator |
| |
| Topical Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical liquid lidocaine | Drug | active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During Phase II (0-4 weeks) and during Phase III (5-12 weeks) |
| 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". | Enrollment visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Eligibility Criteria
Women aged 18 to 70 years old.
Has a previous diagnosis of breast cancer (ductal or lobular carcinoma, invasive).
1 year from diagnosis of breast cancer.
Stable heterosexual partnership =/>5 years or by investigator discretion.
More than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain).
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).
Willingness to enter a study comparing a topical placebo liquid to topical liquid lidocaine.
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
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| Name | Affiliation | Role |
|---|---|---|
| Martha Goetsch, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26215946 | Derived | Goetsch MF, Lim JY, Caughey AB. A Practical Solution for Dyspareunia in Breast Cancer Survivors: A Randomized Controlled Trial. J Clin Oncol. 2015 Oct 20;33(30):3394-400. doi: 10.1200/JCO.2014.60.7366. Epub 2015 Jul 27. | |
| 24807329 | Derived | Goetsch MF, Lim JY, Caughey AB. Locating pain in breast cancer survivors experiencing dyspareunia: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1231-1236. doi: 10.1097/AOG.0000000000000283. |
| Label | URL |
|---|---|
| Related Info | View source |
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January 2012 to June 2013; Women's Health Research Unit (WHRU) at Oregon Health and Science University (OHSU) in Portland, OR
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Liquid Lidocaine | Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule |
| FG001 | Topical Saline | Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Liquid Lidocaine | Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule |
| BG001 | Topical Saline | Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Inter-Quartile Range | Units on a scale | During Phase II (0-4 weeks) and during Phase III (5-12 weeks) |
|
1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical Liquid Lidocaine | Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martha Goetsch | Oregon Health and Science University | 503-494-3666 | whru@ohsu.edu |
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| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| D004414 | Dyspareunia |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D014867 | Water |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Topical saline | Drug | saline applied to the vestibule mucosa will not reverse the local tenderness |
|
|
| Visit 1 (Enrollment) |
| 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). | Visit 2 (Week 4) |
| 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). | Visit 3 (End of Study) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Topical Liquid Lidocaine | Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness |
| OG002 | Open Label | During Open-label Lidocaine 8 weeks Each prior arm converted to use of open label lidocaine for 2 further months. |
|
|
|
| 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). | Averaged scores of Sexual Function Questionnaire Visit 1 each time scoring from the prior 30 days. | Posted | Mean | Inter-Quartile Range | units on a scale | Visit 1 (Enrollment) |
|
|
|
|
| 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". | Posted | Median | Inter-Quartile Range | units on a scale from 0 to 10 | Enrollment visit |
|
|
|
|
| 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). | Averaged scores of Sexual Function Questionnaire at Visit 2 scoring from the prior 30 days. | Posted | Mean | Inter-Quartile Range | Units on a scale | Visit 2 (Week 4) |
|
|
|
| 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). | Averaged scores of Sexual Function Questionnaire at Visit 1 scoring from the prior 30 days. | Posted | Mean | Inter-Quartile Range | Units on a scale | Visit 3 (End of Study) |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Topical Saline | Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule | 0 | 25 | 0 | 25 |
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| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017670 |
| Sodium Compounds |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| Arousal Lubrication |
|
| Arousal Cognitive |
|
| Orgasm |
|
| Pain |
|
| Enjoyment |
|
| Partner |
|
| 0.11 |
| Superiority or Other |
| Arousal (L) | Wilcoxon (Mann-Whitney) | 0.15 | Superiority or Other |
| Arousal (C) | Wilcoxon (Mann-Whitney) | 0.28 | Superiority or Other |
| Orgasm | Wilcoxon (Mann-Whitney) | 0.07 | Superiority or Other |
| Pain | Wilcoxon (Mann-Whitney) | 0.004 | Superiority or Other |
| Enjoyment | Wilcoxon (Mann-Whitney) | 0.54 | Superiority or Other |
| Partner | Wilcoxon (Mann-Whitney) | 0.92 | Superiority or Other |
| 12 o'clock |
|
| 3 o'clock |
|
| 4 o'clock |
|
| 8 o'clock |
|
| 9 o'clock |
|
| 6 o'clock |
|
| Arousal Lubrication |
|
| Arousal Cognitive |
|
| Orgasm |
|
| Pain |
|
| Enjoyment |
|
| Partner |
|
| Arousal Lubrication |
|
| Arousal Cognitive |
|
| Orgasm |
|
| Pain |
|
| Enjoyment |
|
| Partner |
|