Trial · NCT01539317

Therapy to Prevent Sexual Pain in Breast Cancer Survivors

NCT01539317, Phase 3, Completed, OHSU Knight Cancer Institute; results first posted 2015-08-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Therapy to Prevent Sexual Pain in Breast Cancer Survivors. Trials, record NCT01539317. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01539317

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Therapy to Prevent Sexual Pain in Breast Cancer Survivors
NCT number: NCT01539317
Status: Completed
Phases: Phase 3
Enrollment: 50 participants, actual
Lead sponsor: OHSU Knight Cancer Institute
Conditions: Vulvodynia, Dyspareunia, Breast Cancer, Menopause
Interventions: Topical liquid lidocaine, Topical saline
First posted: 2012-02-27
Last updated: 2017-04-14
Results first posted: 2015-08-04

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.
Primary	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	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).
Secondary	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).
Secondary	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).

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Prevention of Entry Dyspareunia With Non-hormonal Therapy	During Phase II (0-4 weeks) and during Phase III (5-12 weeks)		Units on a scale	MEAN
SECONDARY	Improvement of Quality of Sexual Life - Visit 1	Visit 1 (Enrollment)	Averaged scores of Sexual Function Questionnaire Visit 1 each time scoring from the prior 30 days.	units on a scale	MEAN
PRIMARY	Location of Pain in Postmenopausal Dyspareunia	Enrollment visit		units on a scale from 0 to 10	MEDIAN
SECONDARY	Improvement of Quality of Sexual Life - Visit 2	Visit 2 (Week 4)	Averaged scores of Sexual Function Questionnaire at Visit 2 scoring from the prior 30 days.	Units on a scale	MEAN
SECONDARY	Improvement of Quality of Sexual Life - Visit 3	Visit 3 (End of Study)	Averaged scores of Sexual Function Questionnaire at Visit 1 scoring from the prior 30 days.	Units on a scale	MEAN

Source ClinicalTrials.gov

Results by group70

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Prevention of Entry Dyspareunia With Non-hormonal Therapy	Topical Saline	Phase II	5.3	Inter-Quartile Range 3 to 7	Units on a scale
Prevention of Entry Dyspareunia With Non-hormonal Therapy	Topical Liquid Lidocaine	Phase II	1.04	Inter-Quartile Range 0.65 to 1.92	Units on a scale
Prevention of Entry Dyspareunia With Non-hormonal Therapy	Open Label	Phase II	NA	Inter-Quartile Range NA to NA	Units on a scale
Prevention of Entry Dyspareunia With Non-hormonal Therapy	Topical Saline	Phase III	0.57	Inter-Quartile Range 0.07 to 1.80	Units on a scale
Prevention of Entry Dyspareunia With Non-hormonal Therapy	Topical Liquid Lidocaine	Phase III	0.45	Inter-Quartile Range 0 to 1.14	Units on a scale
Prevention of Entry Dyspareunia With Non-hormonal Therapy	Open Label	Phase III	0.48	Inter-Quartile Range 0 to 1.78	Units on a scale
Improvement of Quality of Sexual Life - Visit 1	Topical Saline	Desire	11.91	Inter-Quartile Range 9 to 14	units on a scale
Improvement of Quality of Sexual Life - Visit 1	Topical Liquid Lidocaine	Desire	13.87	Inter-Quartile Range 12 to 16	units on a scale
Improvement of Quality of Sexual Life - Visit 1	Topical Saline	Arousal Sensation	8.44	Inter-Quartile Range 6 to 11	units on a scale
Improvement of Quality of Sexual Life - Visit 1	Topical Liquid Lidocaine	Arousal Sensation	9.15	Inter-Quartile Range 8 to 10	units on a scale

1 to 10 of 70Source ClinicalTrials.gov

See all 70 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Topical Liquid Lidocaine	25
Overall Study	STARTED	Topical Saline	25
Overall Study	COMPLETED	Topical Liquid Lidocaine	24
Overall Study	COMPLETED	Topical Saline	25
Overall Study	NOT COMPLETED	Topical Liquid Lidocaine	1
Overall Study	NOT COMPLETED	Topical Saline	0

Source ClinicalTrials.gov

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Topical Liquid Lidocaine
Total, all-cause mortality	Topical Saline
Total, other adverse events	Topical Liquid Lidocaine	0	25
Total, other adverse events	Topical Saline	0	25
Total, serious adverse events	Topical Liquid Lidocaine	0	25
Total, serious adverse events	Topical Saline	0	25

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24807329	DERIVED	PubMed
26215946	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Topical Liquid Lidocaine vs Topical Saline: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01539317

GET https://conductscience.org/api/trials/v1/NCT01539317/results?page=2

API reference For AI assistants