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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryChange From Baseline Hot Flash FrequencyRepeated change from baseline to 5 and 12 weeksChange 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.
SecondaryChange From Baseline Hot Flash Related Daily Interference Scale (HFRDIS) ScoreRepeated 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
SecondaryChange From Baseline Menopause Quality of Life (MENQOL), Vasomotor Domain ScoreRepeated 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
SecondaryChange From Baseline in Pittsburgh Sleep Quality Index (PSQI) ScoreRepeated 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
SecondaryChange From Baseline Generalized Anxiety Disorder-7 (GAD-7) ScoreRepeated 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
SecondaryChange From Baseline Center for Epidemiologic Studies Depression (CES-D) ScoreRepeated 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.
SecondaryChange in Baseline Frequency of Moderate-to-severe Hot FlashesRepeated change from baseline to 5 and 12 weeksChange 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
SecondaryChange in Baseline Total Hot Flash Severity ScoreRepeated 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.
OtherNumber 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 weeksNumber of participants with treatment related severe adverse events defined by Common Terminology Criteria for Adverse Events (CTCAE) severity grade 3 or higher.

Outcomes9

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline Hot Flash FrequencyRepeated change from baseline to 5 and 12 weeksHot flashes per dayLEAST_SQUARES_MEAN
SECONDARYChange From Baseline Hot Flash Related Daily Interference Scale (HFRDIS) ScoreRepeated change from baseline to 5 and 12 weeksunits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline Menopause Quality of Life (MENQOL), Vasomotor Domain ScoreRepeated change from baseline to 5 and 12 weeksunits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Pittsburgh Sleep Quality Index (PSQI) ScoreRepeated change from baseline to 5 and 12 weeksscore on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline Generalized Anxiety Disorder-7 (GAD-7) ScoreRepeated change from baseline to 5 and 12 weeksunits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline Center for Epidemiologic Studies Depression (CES-D) ScoreRepeated change from baseline to 5 and 12 weeksunits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Baseline Frequency of Moderate-to-severe Hot FlashesRepeated change from baseline to 5 and 12 weeksHot flashes per dayLEAST_SQUARES_MEAN
SECONDARYChange in Baseline Total Hot Flash Severity ScoreRepeated change from baseline to 5 and 12 weeksunits on a scaleLEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIEDNumber 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 weeksParticipantsCOUNT_OF_PARTICIPANTS

Results by group18

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

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline Hot Flash FrequencyTransdermal Nitroglycerin-4.5695% Confidence Interval -6.01 to -3.11Hot flashes per day
Change From Baseline Hot Flash FrequencyPlacebo-4.0295% Confidence Interval -5.41 to -2.63Hot flashes per day
Change From Baseline Hot Flash Related Daily Interference Scale (HFRDIS) ScoreTransdermal Nitroglycerin-19.8595% Confidence Interval -28.5 to -11.2units on a scale
Change From Baseline Hot Flash Related Daily Interference Scale (HFRDIS) ScorePlacebo-20.3695% Confidence Interval -28.61 to -12.12units on a scale
Change From Baseline Menopause Quality of Life (MENQOL), Vasomotor Domain ScoreTransdermal Nitroglycerin-1.5395% Confidence Interval -2.42 to -0.64units on a scale
Change From Baseline Menopause Quality of Life (MENQOL), Vasomotor Domain ScorePlacebo-1.3395% Confidence Interval -2.17 to -0.49units on a scale
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) ScoreTransdermal Nitroglycerin-1.2795% Confidence Interval -2.23 to -0.31score on a scale
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) ScorePlacebo-1.1895% Confidence Interval -2.1 to -0.26score on a scale
Change From Baseline Generalized Anxiety Disorder-7 (GAD-7) ScoreTransdermal Nitroglycerin-0.1595% Confidence Interval -1.18 to 0.89units on a scale
Change From Baseline Generalized Anxiety Disorder-7 (GAD-7) ScorePlacebo-0.5795% Confidence Interval -1.56 to 0.42units on a scale

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDTransdermal Nitroglycerin70
Overall StudySTARTEDPlacebo71
Overall StudyCOMPLETEDTransdermal Nitroglycerin66
Overall StudyCOMPLETEDPlacebo70
Overall StudyNOT COMPLETEDTransdermal Nitroglycerin4
Overall StudyNOT COMPLETEDPlacebo1

Adverse events124

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherHeart FlutteringCardiac disordersTransdermal Nitroglycerin0700
otherHeart FlutteringCardiac disordersPlacebo1711
otherPalpitationsCardiac disordersTransdermal Nitroglycerin1701
otherPalpitationsCardiac disordersPlacebo1711
otherVertigoEar and labyrinth disordersTransdermal Nitroglycerin1701
otherVertigoEar and labyrinth disordersPlacebo1711
otherDiarrheaGastrointestinal disordersTransdermal Nitroglycerin0700
otherDiarrheaGastrointestinal disordersPlacebo1711
otherDry MouthGastrointestinal disordersTransdermal Nitroglycerin0700
otherDry MouthGastrointestinal disordersPlacebo1711

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityTransdermal Nitroglycerin070
Total, all-cause mortalityPlacebo071
Total, other adverse eventsTransdermal Nitroglycerin6570
Total, other adverse eventsPlacebo6671
Total, serious adverse eventsTransdermal Nitroglycerin070
Total, serious adverse eventsPlacebo071

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
37273224DERIVED

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01AG050588Transdermal Nitroglycerin Therapy for Menopausal Hot FlashesHUANG, ALISONUNIVERSITY OF CALIFORNIA, SAN FRANCISCONATIONAL INSTITUTE ON AGING2016 to 2019

Trial comparisons3

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

ComparisonSource
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 causeTrial comparisons
Transdermal Nitroglycerin vs Placebo: serious adverse eventsTrial 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/NCT02714205

GET https://conductscience.org/api/trials/v1/NCT02714205/events?page=2