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Eligibility
for females ages 40 years to 62 years
Healthy Volunteers
healthy people welcome
Dates
study started
estimated completion:
Principal Investigator

Description

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.

Keywords

Menopausal Hot Flashes Hot flash Nitroglycerin

Eligibility

You can join if…

Open to females ages 40 years to 62 years

  • Women aged 40 to 62 years (consistent with the recent MSFlash hot flash network trials, and likely to maximize enrollment of highly symptomatic women)
  • Postmenopausal or in the late menopausal transition. For this study, postmenopausal status will be defined by: 1) self-reported history of bilateral oophorectomy, 2)follicle stimulating hormone (FSH) levels> 20 mU/mL for those with a self-reported history of hysterectomy without bilateral oophorectomy, or 3) no self-reported history of hysterectomy or oophorectomy, but absence of menses in the past 12 months.Late menopausal transition will be defined by amenorrhea for at least 60 days in the past 12 months within the specified age group.
  • Documentation of an average of 7 or more hot flashes per 24 hours as well as 4 or more moderate-to-severe hot flashes per 24 hours as recorded on a validated 7-day screening symptom diary
  • Willing to refrain from initiating other treatments that are known to affect the frequency of severity hot flashes during the trial period

You CAN'T join if...

  • Current or recent use of NTG or other nitrate-containing medications (i.e., use within 1 month of screening), or intention to use nitrate-containing medication during the interventional period
  • Current or recent use of medications already known to reduce the frequency or severity of hot flashes (e.g., systemic estrogens or progestins in the past 3 months;clonidine, methyldopa, gabapentin, and selective serotonin or norepinephrine reuptake inhibitors (SSRIs/SNRIs) in the past 1 month); or intention to use these medications during the interventional period
  • Current or recent use of phosphodiesterase inhibitor medications (within 1 month of screening), or intention to use these medications during the interventional period
  • Self-reported history of hypertrophic obstructive cardiomyopathy, aortic valve stenosis, or mitral valve stenosis (as conventional contraindications to NTG therapy)
  • Self-reported history of coronary disease (since patients with coronary disease may need NTG therapy for chest pain or may be at increased risk of new coronary events in the setting of nitrate tolerance)
  • Self-reported history of diabetes or 2 or more major risk factors for coronary disease (i.e., smoking, hypertension, or hyperlipidemia with physician-recommended pharmacologic treatment)
  • Hypotension based on measured blood pressure <90/60 at baseline; or uncontrolled hypertension based on measured blood pressure> 180/110 at baseline
  • Self-reported migraine or other headaches requiring pharmacologic treatment on a monthly or more frequent basis (since these may be worsened by NTG therapy)
  • Known skin sensitivity to adhesives (which may generalize to the NTG patches)
  • Unable to complete a brief 3-day run-in period involving the lowest available dose of NTG (0.1 mg/hr)
  • Currently pregnant, gave birth within the past 3 months, or planning pregnancy during the study period
  • Unable or unwilling to provide informed consent, fill out questionnaires, or complete study visits in English
  • Report other conditions that, in the judgment of the investigators, render potential participants highly unlikely to follow the protocol, including plans to move,substance abuse, significant psychiatric problems, or dementia.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02714205
Phase
Phase 4
Lead Scientist
Alison Huang
Study Type
Interventional
Last Updated
January 2017
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