Flushing Reduction Associated With Nitrates

Phase 2 Completed 141 enrolled Alison Huang, MD National Institute on Aging (NIA) · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start: 2017-04-24
Primary completion: 2022-03-08
Completion: 2022-04-05

Outcome

Missed primary endpoint

registry analysis (superiority test); Transdermal Nitroglycerin vs Placebo; p = 0.34; Model generated Least Square Mean -0.54 (95% CI -1.66 to 0.58); Mixed Models Analysis NCT02714205 ↗

Publications

Huang AJ, Cummings SR, Ganz P, Schembri M, Raghunathan H, Vittinghoff E, Gibson CJ, Grady D. 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 Aug 1;183(8):776-783. doi: 10.1001/jamainternmed.2023.1977.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nitroglycerin	Unknown	0.6 mg	Other

Indications

No indication recorded.