A randomized, double-blinded, placebo-controlled trial of uninterrupted transdermal nitrate therapy in 140 peri- or postmenopausal women who have frequent hot flashes. Women will be randomly assigned to uninterrupted use of transdermal nitrate therapy (participant directed dose-escalation of 0.2 to 0.6 mg/hr) or identical-appearing placebo patches for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
141
Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
University of California, San Francisco
Oakland, California, United States
University of California, San Francisco
San Francisco, California, United States
Change From Baseline Hot Flash Frequency
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.
Time frame: Repeated change from baseline to 5 and 12 weeks
Change From Baseline Hot Flash Related Daily Interference Scale (HFRDIS) Score
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
Time frame: Repeated change from baseline to 5 and 12 weeks
Change From Baseline Menopause Quality of Life (MENQOL), Vasomotor Domain Score
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
Time frame: Repeated change from baseline to 5 and 12 weeks
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score
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
Time frame: Repeated change from baseline to 5 and 12 weeks
Change From Baseline Generalized Anxiety Disorder-7 (GAD-7) Score
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
Time frame: Repeated change from baseline to 5 and 12 weeks
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Change From Baseline Center for Epidemiologic Studies Depression (CES-D) Score
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.
Time frame: Repeated change from baseline to 5 and 12 weeks
Change in Baseline Frequency of Moderate-to-severe Hot Flashes
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
Time frame: Repeated change from baseline to 5 and 12 weeks
Change in Baseline Total Hot Flash Severity Score
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.
Time frame: Repeated change from baseline to 5 and 12 weeks