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Vasodilator

transdermal nitroglycerin for Hot Flashes (FRAN Trial)

Phase 2
Waitlist Available
Led By Alison Huang, MD, MPhil, MAS
Research Sponsored by Alison Huang, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up repeated change from baseline to 5 and 12 weeks
Awards & highlights

FRAN Trial Summary

This study is evaluating whether a patch which delivers a low dose of nitroglycerin may help reduce hot flashes in women.

Eligible Conditions
  • Hot Flashes

FRAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

FRAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~repeated change from baseline to 5 and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and repeated change from baseline to 5 and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline Hot Flash Frequency
Secondary outcome measures
Change From Baseline Center for Epidemiologic Studies Depression (CES-D) Score
Change From Baseline Generalized Anxiety Disorder-7 (GAD-7) Score
Change From Baseline Hot Flash Related Daily Interference Scale (HFRDIS) Score
+4 more
Other outcome measures
Number of Participants With Treatment Related Severe Adverse Events Defined by Common Terminology Criteria for Adverse Events (CTCAE) Severity Grade 3 or Higher.

Side effects data

From 2022 Phase 2 trial • 141 Patients • NCT02714205
83%
Headache
11%
Localised Rash
10%
Upper Respiratory Infection
7%
Dizziness
4%
Nausea
3%
Hand Pain
3%
Skin Burning Sensation
1%
Thigh Strain
1%
Chest Pain
1%
Rib Fracture
1%
Depression Nos
1%
Chest Pressure Sensation
1%
Ductal Carcinoma In Situ
1%
Arm Discomfort
1%
Vertigo
1%
Agitation
1%
Photosensitivity
1%
Feelings Of Weakness
1%
Chest Pain Aggravated
1%
Soft Stools
1%
Mosquito Bite
1%
Palpitations
1%
Stomach Discomfort
1%
Pruritic Rash
1%
Skin Erythema
1%
Breast Cellulitis
1%
Lost Consciousness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Transdermal Nitroglycerin
Placebo

FRAN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transdermal NitroglycerinExperimental Treatment1 Intervention
Daily transdermal nitroglycerin patch, starting at 0.2 mg/hr. Dose escalation up to 0.6 mg/hr.
Group II: PlaceboPlacebo Group1 Intervention
Daily transdermal placebo patch.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transdermal nitroglycerin
2017
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,667 Previous Clinical Trials
28,005,052 Total Patients Enrolled
9 Trials studying Hot Flashes
1,536 Patients Enrolled for Hot Flashes
Alison Huang, MDLead Sponsor
Alison Huang, MD, MPhil, MASPrincipal Investigator - University of California, San Francisco
UCSF Medical Center at Parnassus
University Of California (Medical School)
University Ca Sf School Of Medicine (Residency)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Flushing Reduction Associated With Nitrates
Alison Huang, MD 2017. "Flushing Reduction Associated With Nitrates". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02714205.
~18 spots leftby Apr 2025
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