Trial · NCT02714205
Flushing Reduction Associated With Nitrates
NCT02714205, Phase 2, Completed, Alison Huang, MD; results first posted 2023-05-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Flushing Reduction Associated With Nitrates. Trials, record NCT02714205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02714205
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Flushing Reduction Associated With Nitrates
- NCT number
- NCT02714205
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 141 participants, actual
- Lead sponsor
- Alison Huang, MD
- Conditions
- Menopausal Hot Flashes
- Interventions
- transdermal nitroglycerin, Placebo
- First posted
- 2016-03-21
- Last updated
- 2025-03-28
- Results first posted
- 2023-05-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline Hot Flash Frequency | Repeated change from baseline to 5 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points. |
| Secondary | Change From Baseline Hot Flash Related Daily Interference Scale (HFRDIS) Score | Repeated change from baseline to 5 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points. Range 0-100, Higher score indicates lower quality of life |
| Secondary | Change From Baseline Menopause Quality of Life (MENQOL), Vasomotor Domain Score | Repeated change from baseline to 5 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points. Range 1-8, Higher score indicates lower quality of life |
| Secondary | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score | Repeated change from baseline to 5 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points Range 0-21, Higher score indicates lower quality of life |
| Secondary | Change From Baseline Generalized Anxiety Disorder-7 (GAD-7) Score | Repeated change from baseline to 5 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points Range 0-21, Higher score indicates lower quality of life |
| Secondary | Change From Baseline Center for Epidemiologic Studies Depression (CES-D) Score | Repeated change from baseline to 5 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points Range 0-60, a higher score indicates a lower quality of life. |
| Secondary | Change in Baseline Frequency of Moderate-to-severe Hot Flashes | Repeated change from baseline to 5 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points |
| Secondary | Change in Baseline Total Hot Flash Severity Score | Repeated change from baseline to 5 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points. The hot flash severity score is calculated as the sum of severity ratings for all hot flashes recorded on the symptom over a 7-day period (mild=1, moderate=2, severe=3), and then divided by 7 for the daily average score. Range 12-60, higher score indicates lower quality of life. |
| Other | Number of Participants With Treatment Related Severe Adverse Events Defined by Common Terminology Criteria for Adverse Events (CTCAE) Severity Grade 3 or Higher. | Baseline to 12 weeks | Number of participants with treatment related severe adverse events defined by Common Terminology Criteria for Adverse Events (CTCAE) severity grade 3 or higher. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline Hot Flash Frequency | Repeated change from baseline to 5 and 12 weeks | Hot flashes per day | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline Hot Flash Related Daily Interference Scale (HFRDIS) Score | Repeated change from baseline to 5 and 12 weeks | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline Menopause Quality of Life (MENQOL), Vasomotor Domain Score | Repeated change from baseline to 5 and 12 weeks | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score | Repeated change from baseline to 5 and 12 weeks | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline Generalized Anxiety Disorder-7 (GAD-7) Score | Repeated change from baseline to 5 and 12 weeks | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline Center for Epidemiologic Studies Depression (CES-D) Score | Repeated change from baseline to 5 and 12 weeks | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Baseline Frequency of Moderate-to-severe Hot Flashes | Repeated change from baseline to 5 and 12 weeks | Hot flashes per day | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Baseline Total Hot Flash Severity Score | Repeated change from baseline to 5 and 12 weeks | units on a scale | LEAST_SQUARES_MEAN | |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment Related Severe Adverse Events Defined by Common Terminology Criteria for Adverse Events (CTCAE) Severity Grade 3 or Higher. | Baseline to 12 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline Hot Flash Frequency | Transdermal Nitroglycerin | -4.56 | 95% Confidence Interval -6.01 to -3.11 | Hot flashes per day | |
| Change From Baseline Hot Flash Frequency | Placebo | -4.02 | 95% Confidence Interval -5.41 to -2.63 | Hot flashes per day | |
| Change From Baseline Hot Flash Related Daily Interference Scale (HFRDIS) Score | Transdermal Nitroglycerin | -19.85 | 95% Confidence Interval -28.5 to -11.2 | units on a scale | |
| Change From Baseline Hot Flash Related Daily Interference Scale (HFRDIS) Score | Placebo | -20.36 | 95% Confidence Interval -28.61 to -12.12 | units on a scale | |
| Change From Baseline Menopause Quality of Life (MENQOL), Vasomotor Domain Score | Transdermal Nitroglycerin | -1.53 | 95% Confidence Interval -2.42 to -0.64 | units on a scale | |
| Change From Baseline Menopause Quality of Life (MENQOL), Vasomotor Domain Score | Placebo | -1.33 | 95% Confidence Interval -2.17 to -0.49 | units on a scale | |
| Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score | Transdermal Nitroglycerin | -1.27 | 95% Confidence Interval -2.23 to -0.31 | score on a scale | |
| Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score | Placebo | -1.18 | 95% Confidence Interval -2.1 to -0.26 | score on a scale | |
| Change From Baseline Generalized Anxiety Disorder-7 (GAD-7) Score | Transdermal Nitroglycerin | -0.15 | 95% Confidence Interval -1.18 to 0.89 | units on a scale | |
| Change From Baseline Generalized Anxiety Disorder-7 (GAD-7) Score | Placebo | -0.57 | 95% Confidence Interval -1.56 to 0.42 | units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Transdermal Nitroglycerin | 70 | |
| Overall Study | STARTED | Placebo | 71 | |
| Overall Study | COMPLETED | Transdermal Nitroglycerin | 66 | |
| Overall Study | COMPLETED | Placebo | 70 | |
| Overall Study | NOT COMPLETED | Transdermal Nitroglycerin | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events124
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 | Heart Fluttering | Cardiac disorders | Transdermal Nitroglycerin | 0 | 70 | 0 |
| other | Heart Fluttering | Cardiac disorders | Placebo | 1 | 71 | 1 |
| other | Palpitations | Cardiac disorders | Transdermal Nitroglycerin | 1 | 70 | 1 |
| other | Palpitations | Cardiac disorders | Placebo | 1 | 71 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Transdermal Nitroglycerin | 1 | 70 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 71 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Transdermal Nitroglycerin | 0 | 70 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 1 | 71 | 1 |
| other | Dry Mouth | Gastrointestinal disorders | Transdermal Nitroglycerin | 0 | 70 | 0 |
| other | Dry Mouth | Gastrointestinal disorders | Placebo | 1 | 71 | 1 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Transdermal Nitroglycerin | 0 | 70 |
| Total, all-cause mortality | Placebo | 0 | 71 |
| Total, other adverse events | Transdermal Nitroglycerin | 65 | 70 |
| Total, other adverse events | Placebo | 66 | 71 |
| Total, serious adverse events | Transdermal Nitroglycerin | 0 | 70 |
| Total, serious adverse events | Placebo | 0 | 71 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37273224 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| R01AG050588 | Transdermal Nitroglycerin Therapy for Menopausal Hot Flashes | HUANG, ALISON | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL INSTITUTE ON AGING | 2016 to 2019 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Transdermal Nitroglycerin vs Placebo: Number of Participants With Treatment Related Severe Adverse Events Defined by Common Terminology Criteria for Adverse Events (CTCAE) Severity Grade 3 or Higher. | Trial comparisons |
| Transdermal Nitroglycerin vs Placebo: deaths from any cause | Trial comparisons |
| Transdermal Nitroglycerin vs Placebo: serious adverse events | 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.
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/NCT02714205
GET https://conductscience.org/api/trials/v1/NCT02714205/events?page=2