Clinical Trial: Flushing Reduction Associated With Nitrates
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Flushing Reduction Associated With Nitrates
Brief 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.
Detailed Summary:
Sponsor: University of California, San Francisco
Current Primary Outcome: Change from baseline hot flash frequency at 12 weeks. [ Time Frame: Baseline and 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline Hot Flash Related Daily Interference Scale (HFRDIS) score at 12 weeks. [ Time Frame: Baseline and 12 weeks ]
- Change from baseline Menopause Quality of Life (MENQOL) score at 12 weeks. [ Time Frame: Baseline and 12 weeks ]
- Change from baseline Pittsburgh Sleep Quality Index (PSQI) score at 12 weeks. [ Time Frame: Baseline and 12 weeks ]
- Change from baseline Generalized Anxiety Disorder-7 (GAD-7) score at 12 weeks. [ Time Frame: Baseline and 12 weeks ]
- Change from baseline Center for Epidemiologic Studies Depression (CES-D) Score at 12 weeks. [ Time Frame: Baseline and 12 weeks ]
- Change in baseline frequency of moderate-to-severe hot flashes at 12 weeks. [ Time Frame: Baseline and 12 weeks ]
- Change in baseline total hot flash severity score at 12 weeks. [ Time Frame: Baseline and 12 weeks ]
Original Secondary Outcome: Same as current
Information By: University of California, San Francisco
Dates:
Date Received: March 11, 2016
Date Started: April 24, 2017
Date Completion: April 2020
Last Updated: April 24, 2017
Last Verified: April 2017
