6/28/23, 10:40 PM FRAN Pathway Feedback Search Clinical Topics Home Studies FRAN FRAN Disease Menopause Trial question What is the effect of continuous transdermal nitroglycerin patches in women with menopause- related hot flashes? Study design Single center Double blinded RCT Population 134 female patients Inclusion criteria: perimenopausal or postmenopausal women reporting 7 hot flashes per day Key exclusion criteria: use of nitroglycerin or other nitrate-containing medications during the past 4 weeks; vaginal estrogen or progestins during the past 4 weeks or systemic estrogen during the past 12 weeks; other medications with potential efficacy for hot flashes during the past 4 weeks Interventions N=65 nitroglycerin (transdermal nitroglycerin participant-directed dose titration from 0.2-0.6 mg/hour) N=69 placebo (matching placebo patches) Primary outcome Reduction in hot flash frequency per day at week 5 4.5 4.5 3.6 3.4 2.3 1.1 No significant difference 0.0 https://web.pathway.md/studies/recELByEqDefeNPp6 1/2 6/28/23, 10:40 PM FRAN Pathway Nitroglycerin Placebo No significant difference in reduction in hot flash frequency per day at week 5 (4.5 vs. 3.6; AD 0.9, 95% CI -2.1 to 0.3) Secondary outcomes Borderline significant increase in reduction in moderate-to-severe hot flashes per day at week 5 (3.3 vs. 2.2; AD 1.1, 95% CI 0 to 2.2) No significant difference in reduction in total daily diary-based hot flash severity score at week 5 (8.3 vs. 6.1; AD 2.2, 95% CI -0.4 to 4.7) No significant difference in reduction in hot flash frequency per day at week 12 (4.6 vs. 4.7; AD -0.1, 95% CI -1.2 to 1.4) Safety outcomes No significant differences in adverse event, headache. Significant difference in headache at week 1 (65.7% vs. 5.6%). Conclusion In perimenopausal or postmenopausal women reporting 7 hot flashes per day, nitroglycerin was not superior to placebo with respect to reduction in hot flash frequency per day at week 5. Reference Alison J Huang, Steven R Cummings, Peter Ganz et al. Efficacy of Continuous Transdermal Nitroglycerin for Treating Hot Flashes by Inducing Nitrate Cross-tolerance in Perimenopausal and Postmenopausal Women: A Randomized Clinical Trial. JAMA Intern Med. 2023 Jun 5;e231977. Open reference URL https://web.pathway.md/studies/recELByEqDefeNPp6 2/2