Trial · NCT01422408
Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
NCT01422408, Phase 2, Completed, OHSU Knight Cancer Institute; results first posted 2017-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy. Trials, record NCT01422408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01422408
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
- NCT number
- NCT01422408
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- OHSU Knight Cancer Institute
- Conditions
- Breast Carcinoma
- Interventions
- Fluocinonide Cream, Management of Therapy Complications, Questionnaire Administration
- First posted
- 2011-08-24
- Last updated
- 2017-08-09
- Results first posted
- 2017-08-09
- Limitations and caveats
Original plan was to use GEE modeling for secondary analysis of primary endpoints. Missing data and small counts caused us to perform this analysis using other statistical methods. Data was categorized and tested using McNemar's Test for results
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Symptom Scores of Vaginal Dryness | Baseline and 4 weeks | Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Primary | Change in Symptom Scores of Dyspareunia | Baseline and 4 weeks | Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Symptom Scores of Vaginal Itching | Baseline and 4 weeks | Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Total Vaginal Index Score. | Baseline and 4 weeks | Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints. |
| Secondary | Number of Patients Experiencing Toxicities | Over 4 weeks | Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set. |
| Secondary | Change in Vaginal Dryness Symptom Scores by Age Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dryness and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Dyspareunia Symptom Scores by Age Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Vaginal Itching Symptom Scores by Age Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Itching and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Dyspareunia Symptom Scores by Menopause Status Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Symptom Scores of Vaginal Dryness | Baseline and 4 weeks | units on a scale | MEDIAN | |
| PRIMARY | Change in Symptom Scores of Dyspareunia | Baseline and 4 weeks | units on a scale | MEDIAN | |
| SECONDARY | Change in Symptom Scores of Vaginal Itching | Baseline and 4 weeks | units on a scale | MEDIAN | |
| SECONDARY | Change in Total Vaginal Index Score. | Baseline and 4 weeks | units on a scale | MEDIAN | |
| SECONDARY | Number of Patients Experiencing Toxicities | Over 4 weeks | Toxicity and safety analyses will be conducted using the safety analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Vaginal Dryness Symptom Scores by Age Characteristics | Baseline and 4 weeks | The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number. | units on a scale | MEDIAN |
| SECONDARY | Change in Dyspareunia Symptom Scores by Age Characteristics | Baseline and 4 weeks | The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number. | units on a scale | MEDIAN |
| SECONDARY | Change in Vaginal Itching Symptom Scores by Age Characteristics | Baseline and 4 weeks | The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number. | units on a scale | MEDIAN |
| SECONDARY | Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics | Baseline and 4 weeks | The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number. | units on a scale | MEDIAN |
| SECONDARY | Change in Dyspareunia Symptom Scores by Menopause Status Characteristics | Baseline and 4 weeks | The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number. | units on a scale | MEDIAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group71
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Symptom Scores of Vaginal Dryness | Supportive Care (Fluocinonide Cream) | -2 | Inter-Quartile Range -3 to -1 | units on a scale | |
| Change in Symptom Scores of Dyspareunia | Supportive Care (Fluocinonide Cream) | -2 | Inter-Quartile Range -3 to -1.8 | units on a scale | |
| Change in Symptom Scores of Vaginal Itching | Supportive Care (Fluocinonide Cream) | -1 | Inter-Quartile Range -2 to 0 | units on a scale | |
| Change in Total Vaginal Index Score. | Supportive Care (Fluocinonide Cream) | -5 | Inter-Quartile Range -6 to -3.8 | units on a scale | |
| Number of Patients Experiencing Toxicities | Supportive Care (Fluocinonide Cream) | 1 | Participants | ||
| Change in Vaginal Dryness Symptom Scores by Age Characteristics | Supportive Care (Fluocinonide Cream) | Age 18-45 | -1.5 | Inter-Quartile Range -2.5 to -1.0 | units on a scale |
| Change in Vaginal Dryness Symptom Scores by Age Characteristics | Supportive Care (Fluocinonide Cream) | Age 46-55 | -2.0 | Inter-Quartile Range -3.0 to -2.0 | units on a scale |
| Change in Vaginal Dryness Symptom Scores by Age Characteristics | Supportive Care (Fluocinonide Cream) | Age 56-65 | -2.0 | Inter-Quartile Range -2.0 to -1.5 | units on a scale |
| Change in Vaginal Dryness Symptom Scores by Age Characteristics | Supportive Care (Fluocinonide Cream) | Age > 65 | -2.0 | Inter-Quartile Range -3.0 to -0.75 | units on a scale |
| Change in Dyspareunia Symptom Scores by Age Characteristics | Supportive Care (Fluocinonide Cream) | Age 18-45 | -1 | Inter-Quartile Range -1 to -1 | units on a scale |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Supportive Care (Fluocinonide Cream) | 34 | |
| Overall Study | COMPLETED | Supportive Care (Fluocinonide Cream) | 30 | |
| Overall Study | NOT COMPLETED | Supportive Care (Fluocinonide Cream) | 4 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bullous dermatitis | Skin and subcutaneous tissue disorders | Supportive Care (Fluocinonide Cream) | 1 | 34 | 1 |
| other | Flushing | Skin and subcutaneous tissue disorders | Supportive Care (Fluocinonide Cream) | 1 | 34 | 1 |
| other | Headache | General disorders | Supportive Care (Fluocinonide Cream) | 1 | 34 | 1 |
| other | Pain of skin | Skin and subcutaneous tissue disorders | Supportive Care (Fluocinonide Cream) | 23 | 34 | 23 |
| other | Pruritis | Skin and subcutaneous tissue disorders | Supportive Care (Fluocinonide Cream) | 1 | 34 | 1 |
| other | Rash acneiform | Skin and subcutaneous tissue disorders | Supportive Care (Fluocinonide Cream) | 1 | 34 | 1 |
| other | Vaginal discharge | Skin and subcutaneous tissue disorders | Supportive Care (Fluocinonide Cream) | 2 | 34 | 2 |
| other | Vaginal inflammation | Skin and subcutaneous tissue disorders | Supportive Care (Fluocinonide Cream) | 1 | 34 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Supportive Care (Fluocinonide Cream) | 0 | 34 |
| Total, other adverse events | Supportive Care (Fluocinonide Cream) | 24 | 34 |
| Total, serious adverse events | Supportive Care (Fluocinonide Cream) | 0 | 34 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA069533 | OHSU Knight Cancer Institute | KUMMAR, SHIVAANI | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1997 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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.
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