Trial · NCT02961790
Oxybutynin Chloride in Managing Hot Flashes
NCT02961790, Phase 3, Completed, Academic and Community Cancer Research United; results first posted 2019-06-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oxybutynin Chloride in Managing Hot Flashes. Trials, record NCT02961790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02961790
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oxybutynin Chloride in Managing Hot Flashes
- NCT number
- NCT02961790
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- Academic and Community Cancer Research United
- Conditions
- Breast Carcinoma, Ductal Breast Carcinoma In Situ, Hot Flashes, Lobular Breast Carcinoma In Situ, No Evidence of Disease
- Interventions
- Oxybutynin Chloride, Placebo, Quality-of-Life Assessment, Questionnaire Administration
- First posted
- 2016-11-11
- Last updated
- 2020-01-18
- Results first posted
- 2019-06-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Change in Hot Flash Activity Score From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo | Baseline up to day 49 | Average change in hot flash activity score from baseline to Week 7 for Low Dose Oxybutynin vs Placebo. The hot flash activity will be measured by the weekly average hot flash score (Sloan JA, et. al., 2001), which is a composite entity of both frequency and severity of hot flashes (The Hot Flash Diary collects the following information for Day 1- Day 7 of each week: Number of mild hot flashes, Number of moderate hot flashes, Number of severe hot flashes, Number of very severe hot flashes). This is a count, so it can range from 0 to infinity. |
| Secondary | Average Change in Hot Flash Score From Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo | Baseline up to day 49 | Average change in Hot Flash Score from Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included low dose oxybutynin, weeks 1-7, no current aromatase inhibitor, age group 18-49, no tamoxifen, hot flash symptom duration \< 9 months, and 4-9 hot flashes/day as fixed effects, and participant and error as random effects. The mean change in Hot Flash Score from Week 1 to Week 7 is reported below for the low-dose oxybutynin and placebo groups. |
| Secondary | Average Change in Hot Flash Score From Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo | Baseline up to day 49 | Average change in Hot Flash Score from Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included low dose oxybutynin, weeks 1-7, no current aromatase inhibitor, age group 18-49, no tamoxifen, hot flash symptom duration \< 9 months, and 4-9 hot flashes/day as fixed effects, and participant and error as random effects. The mean change in Hot Flash Score from Week 1 to Week 7 is reported below for the high-dose oxybutynin and placebo groups. |
| Secondary | Average Change of Severity of Stomach Pain/Cramps Symptoms as Measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo | Baseline up to day 49 | Average Change of severity of Stomach pain/cramps symptoms as measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo The Symptom Experience Questionnaire stomach pain/cramps item ("Over the past week, have you experienced stomach pain or cramps?") is scored from 0 to 10 with higher values being worse symptoms. So a negative value means the symptom is improving and a positive score means the symptom is getting worse. |
| Secondary | Average Change of Daily Interference (Work) From Baseline to Week 7 as Measured by the Hot Flash-Related Daily Interference Scale (HFRDIS) Comparing Low Dose Oxybutynin vs Placebo and High Dose Oxybutynin vs Placebo | Baseline up to day 49 | Average Change of daily interference (Work) from baseline to Week 7 as measured by the Hot Flash-Related Daily Interference Scale (HFRDIS) comparing Low dose oxybutynin vs Placebo and High dose oxybutynin vs Placebo. HFRDIS Work item ("Work (work outside the home and housework)") Interference scores run from 0 to 10 with 0 being no interference and 10 being complete interference. |
| Secondary | Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) | Up to 7 weeks | The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Change in Hot Flash Activity Score From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo | Baseline up to day 49 | Patients who received high-dose oxybutynin, low-dose oxybutynin or placebo and completed the Hot Flash Diary at baseline and Week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups. | score on a scale | MEAN |
| SECONDARY | Average Change in Hot Flash Score From Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo | Baseline up to day 49 | Patients who received low-dose oxybutynin or placebo and completed the Hot Flash Diary at baseline and Week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose oxybutynin chloride group. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Average Change in Hot Flash Score From Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo | Baseline up to day 49 | Patients who received higher dose oxybutynin or placebo and completed the Hot Flash Diary at baseline and Week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the high-dose oxybutynin chloride group. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Average Change of Severity of Stomach Pain/Cramps Symptoms as Measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo | Baseline up to day 49 | Patients who completed baseline and week 7 Symptom Experience Questionnaire Stomach pain/cramps item were included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups. | change in score on a scale | MEAN |
| SECONDARY | Average Change of Daily Interference (Work) From Baseline to Week 7 as Measured by the Hot Flash-Related Daily Interference Scale (HFRDIS) Comparing Low Dose Oxybutynin vs Placebo and High Dose Oxybutynin vs Placebo | Baseline up to day 49 | Patients who completed the Hot Flash-Related Daily Interference Scale (HFRDIS) Work item at baseline and week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups. | change in score on a scale | MEAN |
| SECONDARY | Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) | Up to 7 weeks | Patients who received at least one cycle of treatment and were assessed for adverse events were included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Change in Hot Flash Activity Score From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo | High-dose Oxybutynin Chloride Group | -16.9 | Standard Deviation 15.6 | score on a scale | |
| Average Change in Hot Flash Activity Score From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo | Low-dose Oxybutynin Chloride Group | -10.6 | Standard Deviation 7.7 | score on a scale | |
| Average Change in Hot Flash Activity Score From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo | Placebo Group | -5.7 | Standard Deviation 10.2 | score on a scale | |
| Average Change in Hot Flash Score From Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo | Low-dose Oxybutynin Chloride Group | 8.1 | Standard Error 0.63 | score on a scale | |
| Average Change in Hot Flash Score From Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo | Placebo Group | 15.6 | Standard Error 0.66 | score on a scale | |
| Average Change in Hot Flash Score From Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo | High-dose Oxybutynin Chloride Group | 9.8 | Standard Error 0.82 | score on a scale | |
| Average Change in Hot Flash Score From Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo | Placebo Group | 16.2 | Standard Error 0.82 | score on a scale | |
Average Change of Severity of Stomach Pain/Cramps Symptoms as Measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo | High-dose Oxybutynin Chloride Group | 0.0 | Standard Deviation 1.3 | change in score on a scale | |
Average Change of Severity of Stomach Pain/Cramps Symptoms as Measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo | Low-dose Oxybutynin Chloride Group | -0.3 | Standard Deviation 1.5 | change in score on a scale | |
Average Change of Severity of Stomach Pain/Cramps Symptoms as Measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo | Placebo Group | -1.4 | Standard Deviation 2.5 | change in score on a scale |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | High-dose Oxybutynin Chloride Group | 50 | |
| Overall Study | STARTED | Low-dose Oxybutynin Chloride Group | 51 | |
| Overall Study | STARTED | High-dose Placebo Group | 24 | |
| Overall Study | STARTED | Low-dose Placebo Group | 25 | |
| Overall Study | COMPLETED | High-dose Oxybutynin Chloride Group | 35 | |
| Overall Study | COMPLETED | Low-dose Oxybutynin Chloride Group | 40 | |
| Overall Study | COMPLETED | High-dose Placebo Group | 18 | |
| Overall Study | COMPLETED | Low-dose Placebo Group | 20 | |
| Overall Study | NOT COMPLETED | High-dose Oxybutynin Chloride Group | 15 | |
| Overall Study | NOT COMPLETED | Low-dose Oxybutynin Chloride Group | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events75
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 | Blurred vision | Eye disorders | High-dose Oxybutynin Chloride Group | 3 | 46 | 3 |
| other | Blurred vision | Eye disorders | Low-dose Oxybutynin Chloride Group | 1 | 48 | 1 |
| other | Blurred vision | Eye disorders | Placebo Group | 0 | 44 | 0 |
| other | Dry eye | Eye disorders | High-dose Oxybutynin Chloride Group | 3 | 46 | 8 |
| other | Dry eye | Eye disorders | Low-dose Oxybutynin Chloride Group | 0 | 48 | 0 |
| other | Dry eye | Eye disorders | Placebo Group | 0 | 44 | 0 |
| other | Eye disorders - Other, specify | Eye disorders | High-dose Oxybutynin Chloride Group | 1 | 46 | 1 |
| other | Eye disorders - Other, specify | Eye disorders | Low-dose Oxybutynin Chloride Group | 0 | 48 | 0 |
| other | Eye disorders - Other, specify | Eye disorders | Placebo Group | 0 | 44 | 0 |
| other | Constipation | Gastrointestinal disorders | High-dose Oxybutynin Chloride Group | 2 | 46 | 4 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High-dose Oxybutynin Chloride Group | 0 | 46 |
| Total, all-cause mortality | Low-dose Oxybutynin Chloride Group | 0 | 48 |
| Total, all-cause mortality | Placebo Group | 0 | 44 |
| Total, other adverse events | High-dose Oxybutynin Chloride Group | 19 | 46 |
| Total, other adverse events | Low-dose Oxybutynin Chloride Group | 13 | 48 |
| Total, other adverse events | Placebo Group | 8 | 44 |
| Total, serious adverse events | High-dose Oxybutynin Chloride Group | 2 | 46 |
| Total, serious adverse events | Low-dose Oxybutynin Chloride Group | 0 | 48 |
| Total, serious adverse events | Placebo Group | 0 | 44 |
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 |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 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.
GET https://conductscience.org/api/trials/v1/NCT02961790
GET https://conductscience.org/api/trials/v1/NCT02961790/events?page=2