Trial Outcomes & Findings for Therapy to Prevent Sexual Pain in Breast Cancer Survivors (NCT NCT01539317)
NCT ID: NCT01539317
Last Updated: 2017-04-14
Results Overview
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.
COMPLETED
PHASE3
50 participants
During Phase II (0-4 weeks) and during Phase III (5-12 weeks)
2017-04-14
Participant Flow
January 2012 to June 2013; Women's Health Research Unit (WHRU) at Oregon Health and Science University (OHSU) in Portland, OR
Participant milestones
| Measure |
Topical Liquid Lidocaine
Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
|
Topical Saline
Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Topical Liquid Lidocaine
Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
|
Topical Saline
Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
|
|---|---|---|
|
Overall Study
Screening Error. Deleted from analysis.
|
1
|
0
|
Baseline Characteristics
Therapy to Prevent Sexual Pain in Breast Cancer Survivors
Baseline characteristics by cohort
| Measure |
Topical Liquid Lidocaine
n=25 Participants
Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
|
Topical Saline
n=25 Participants
Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
55.34 years
STANDARD_DEVIATION 8.77 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Topical Saline
n=21 Participants
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
|
Topical Liquid Lidocaine
n=22 Participants
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
|
Open Label
n=41 Participants
During Open-label Lidocaine 8 weeks
Each prior arm converted to use of open label lidocaine for 2 further months.
|
|---|---|---|---|
|
Prevention of Entry Dyspareunia With Non-hormonal Therapy
Phase II
|
5.3 Units on a scale
Interval 3.0 to 7.0
|
1.04 Units on a scale
Interval 0.65 to 1.92
|
NA Units on a scale
Phase II was not the open label portion of the study
|
|
Prevention of Entry Dyspareunia With Non-hormonal Therapy
Phase III
|
0.57 Units on a scale
Interval 0.07 to 1.8
|
0.45 Units on a scale
Interval 0.0 to 1.14
|
0.48 Units on a scale
Interval 0.0 to 1.78
|
PRIMARY outcome
Timeframe: Enrollment visitTo 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".
Outcome measures
| Measure |
Topical Saline
n=25 Participants
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
|
Topical Liquid Lidocaine
n=24 Participants
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
|
Open Label
During Open-label Lidocaine 8 weeks
Each prior arm converted to use of open label lidocaine for 2 further months.
|
|---|---|---|---|
|
Location of Pain in Postmenopausal Dyspareunia
1 o'clock
|
0 units on a scale from 0 to 10
Interval 0.0 to 0.0
|
0 units on a scale from 0 to 10
Interval 0.0 to 0.0
|
—
|
|
Location of Pain in Postmenopausal Dyspareunia
11 o'clock
|
0 units on a scale from 0 to 10
Interval 0.0 to 2.0
|
0 units on a scale from 0 to 10
Interval 0.0 to 0.0
|
—
|
|
Location of Pain in Postmenopausal Dyspareunia
12 o'clock
|
1 units on a scale from 0 to 10
Interval 0.0 to 4.0
|
0 units on a scale from 0 to 10
Interval 0.0 to 0.0
|
—
|
|
Location of Pain in Postmenopausal Dyspareunia
3 o'clock
|
3 units on a scale from 0 to 10
Interval 2.0 to 5.0
|
0 units on a scale from 0 to 10
Interval 0.0 to 1.0
|
—
|
|
Location of Pain in Postmenopausal Dyspareunia
4 o'clock
|
4 units on a scale from 0 to 10
Interval 3.0 to 6.0
|
0 units on a scale from 0 to 10
Interval 0.0 to 1.0
|
—
|
|
Location of Pain in Postmenopausal Dyspareunia
8 o'clock
|
4 units on a scale from 0 to 10
Interval 3.0 to 6.0
|
0 units on a scale from 0 to 10
Interval 0.0 to 0.5
|
—
|
|
Location of Pain in Postmenopausal Dyspareunia
9 o'clock
|
5 units on a scale from 0 to 10
Interval 2.0 to 6.0
|
0 units on a scale from 0 to 10
Interval 0.0 to 1.0
|
—
|
|
Location of Pain in Postmenopausal Dyspareunia
6 o'clock
|
2 units on a scale from 0 to 10
Interval 1.0 to 4.0
|
0 units on a scale from 0 to 10
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (Enrollment)Population: Averaged scores of Sexual Function Questionnaire Visit 1 each time scoring from the prior 30 days.
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).
Outcome measures
| Measure |
Topical Saline
n=21 Participants
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
|
Topical Liquid Lidocaine
n=22 Participants
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
|
Open Label
During Open-label Lidocaine 8 weeks
Each prior arm converted to use of open label lidocaine for 2 further months.
|
|---|---|---|---|
|
Improvement of Quality of Sexual Life - Visit 1
Desire
|
11.91 units on a scale
Interval 9.0 to 14.0
|
13.87 units on a scale
Interval 12.0 to 16.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 1
Arousal Sensation
|
8.44 units on a scale
Interval 6.0 to 11.0
|
9.15 units on a scale
Interval 8.0 to 10.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 1
Arousal Lubrication
|
3.92 units on a scale
Interval 2.0 to 4.0
|
2.97 units on a scale
Interval 2.0 to 4.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 1
Arousal Cognitive
|
4.28 units on a scale
Interval 4.0 to 5.0
|
4.82 units on a scale
Interval 4.0 to 6.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 1
Orgasm
|
5.70 units on a scale
Interval 1.0 to 10.0
|
7.62 units on a scale
Interval 1.0 to 13.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 1
Pain
|
6.04 units on a scale
Interval 4.48 to 8.0
|
6.29 units on a scale
Interval 5.0 to 8.48
|
—
|
|
Improvement of Quality of Sexual Life - Visit 1
Enjoyment
|
15.30 units on a scale
Interval 12.0 to 17.68
|
17.01 units on a scale
Interval 14.0 to 18.97
|
—
|
|
Improvement of Quality of Sexual Life - Visit 1
Partner
|
7.78 units on a scale
Interval 6.0 to 9.0
|
8.13 units on a scale
Interval 7.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: Visit 2 (Week 4)Population: Averaged scores of Sexual Function Questionnaire at Visit 2 scoring from the prior 30 days.
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).
Outcome measures
| Measure |
Topical Saline
n=21 Participants
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
|
Topical Liquid Lidocaine
n=22 Participants
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
|
Open Label
During Open-label Lidocaine 8 weeks
Each prior arm converted to use of open label lidocaine for 2 further months.
|
|---|---|---|---|
|
Improvement of Quality of Sexual Life - Visit 2
Desire
|
14 Units on a scale
Interval 11.0 to 17.0
|
16.09 Units on a scale
Interval 14.0 to 19.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 2
Arousal Sensation
|
8.14 Units on a scale
Interval 5.0 to 10.0
|
11.21 Units on a scale
Interval 9.71 to 13.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 2
Arousal Lubrication
|
3.59 Units on a scale
Interval 2.0 to 4.0
|
4.18 Units on a scale
Interval 2.0 to 4.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 2
Arousal Cognitive
|
4.69 Units on a scale
Interval 4.0 to 6.0
|
5.99 Units on a scale
Interval 5.0 to 7.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 2
Orgasm
|
5.07 Units on a scale
Interval 1.0 to 9.0
|
9.05 Units on a scale
Interval 8.0 to 12.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 2
Pain
|
7.96 Units on a scale
Interval 6.0 to 9.26
|
10.50 Units on a scale
Interval 9.13 to 12.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 2
Enjoyment
|
16.9 Units on a scale
Interval 14.0 to 20.54
|
19.36 Units on a scale
Interval 17.07 to 22.07
|
—
|
|
Improvement of Quality of Sexual Life - Visit 2
Partner
|
8.62 Units on a scale
Interval 8.0 to 10.0
|
8.68 Units on a scale
Interval 8.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: Visit 3 (End of Study)Population: Averaged scores of Sexual Function Questionnaire at Visit 1 scoring from the prior 30 days.
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).
Outcome measures
| Measure |
Topical Saline
n=21 Participants
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
|
Topical Liquid Lidocaine
n=22 Participants
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
|
Open Label
During Open-label Lidocaine 8 weeks
Each prior arm converted to use of open label lidocaine for 2 further months.
|
|---|---|---|---|
|
Improvement of Quality of Sexual Life - Visit 3
Desire
|
17.79 Units on a scale
Interval 15.0 to 21.0
|
18.32 Units on a scale
Interval 16.0 to 21.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 3
Arousal Sensation
|
10.89 Units on a scale
Interval 8.0 to 13.0
|
13.15 Units on a scale
Interval 11.0 to 15.5
|
—
|
|
Improvement of Quality of Sexual Life - Visit 3
Arousal Lubrication
|
4.79 Units on a scale
Interval 4.0 to 6.0
|
5.2 Units on a scale
Interval 4.0 to 6.5
|
—
|
|
Improvement of Quality of Sexual Life - Visit 3
Arousal Cognitive
|
5.74 Units on a scale
Interval 5.0 to 7.0
|
7.05 Units on a scale
Interval 6.0 to 9.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 3
Orgasm
|
6.95 Units on a scale
Interval 1.0 to 11.0
|
9.5 Units on a scale
Interval 7.0 to 13.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 3
Pain
|
11.18 Units on a scale
Interval 10.35 to 12.0
|
11.67 Units on a scale
Interval 9.5 to 13.68
|
—
|
|
Improvement of Quality of Sexual Life - Visit 3
Enjoyment
|
20.90 Units on a scale
Interval 17.44 to 24.44
|
22.51 Units on a scale
Interval 21.2 to 24.0
|
—
|
|
Improvement of Quality of Sexual Life - Visit 3
Partner
|
8.95 Units on a scale
Interval 8.0 to 10.0
|
9.36 Units on a scale
Interval 9.0 to 10.0
|
—
|
Adverse Events
Topical Liquid Lidocaine
Topical Saline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Martha Goetsch
Oregon Health and Science University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place