Last updated on June 2018

A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)


Brief description of study

This study is to determine the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes. The treatment will be administered for 12 weeks to postmenopausal women, ages 40 to 65, suffering at least 50 moderate to severe hot flashes per week.

Detailed Study Description

This is a 12-week randomized, double-blind, placebo-controlled, dose-ranging, parallel-group, multicenter study to assess the efficacy of ESN364 in postmenopausal women suffering from vasomotor symptoms (hot flashes).

This study will consist of a screening period (Days -35 to -1, including the screening visit [Visit 1] and a minimum 7-day collection of baseline vasomotor symptom frequency and severity assessments), a 12 week treatment period (Day 1 [Visit 2] to Week 12 [Visit 5]), and a follow up visit (Week 15 [Visit 6]) 3 weeks after the last dose of study drug.

The study will be performed on an ambulatory basis. The screening visit (Visit 1) will occur up to 35 days prior to randomization. Eligibility will be assessed via physical examination, clinical laboratory testing, vital signs, ECG, Pap smear, mammography, and endometrial biopsy. Subjects will receive an electronic diary in which to record daily vasomotor symptoms during the duration of the screening period. Subjects must have 7 consecutive days of vasomotor symptom recordings to participate in the study. Subjects are encouraged to continue recording for the duration of the whole screening period. The electronic diary will be reviewed by study site staff on Day 1 (Visit 2) to confirm study eligibility. Subjects may be rescreened 1 time upon approval of the medical monitor.

During the treatment period, subjects will return to the study site every 4 weeks for assessments.

The follow-up visit will occur approximately 3 weeks following the last dose of study drug.

Clinical Study Identifier: NCT03192176

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Steven Ramael, MD

Research Site
Birmingham, AL United States

Steven Ramael, MD

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Phoenix, AZ United States

Steven Ramael, MD

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Los Angeles, CA United States

Steven Ramael, MD

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Oceanside, CA United States

Steven Ramael, MD

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Panorama City, CA United States

Steven Ramael, MD

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San Diego, CA United States

Steven Ramael, MD

REsearch Site
Thousand Oaks, CA United States

Steven Ramael, MD

Research Site
Denver, CO United States

Steven Ramael, MD

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Milford, CT United States

Steven Ramael, MD

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Crystal River, FL United States

Steven Ramael, MD

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DeLand, FL United States

Steven Ramael, MD

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Jupiter, FL United States

Steven Ramael, MD

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Lake Worth, FL United States

Steven Ramael, MD

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Miami, FL United States

Steven Ramael, MD

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Ormond Beach, FL United States

Steven Ramael, MD

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Port Saint Lucie, FL United States

Steven Ramael, MD

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Norcross, GA United States

Steven Ramael, MD

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Champaign, IL United States

Steven Ramael, MD

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Marrero, LA United States

Steven Ramael, MD

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Watertown, MA United States

Steven Ramael, MD

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Lincoln, NE United States

Steven Ramael, MD

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Norfolk, NE United States

Steven Ramael, MD

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Las Vegas, NV United States

Steven Ramael, MD

Research Site
Columbus, OH United States

Steven Ramael, MD

Research Site
Mount Pleasant, SC United States

Steven Ramael, MD

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Clarksville, TN United States

Steven Ramael, MD

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Hurst, TX United States

Steven Ramael, MD

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Lampasas, TX United States

Steven Ramael, MD

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Plano, TX United States

Steven Ramael, MD

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San Antonio, TX United States

Steven Ramael, MD

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Vienna, VA United States

Steven Ramael, MD

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Seattle, WA United States

Steven Ramael, MD

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Spokane, WA United States

Steven Ramael, MD

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Sacramento, CA United States

Steven Ramael, MD

Research Site
Boise, ID United States

Steven Ramael, MD

Research Site
New York, NY United States

Steven Ramael, MD

Research Site
Williamsville, NY United States

Steven Ramael, MD

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Cincinnati, OH United States

Steven Ramael, MD

Research Site
Cleveland, OH United States

Steven Ramael, MD

Research Site
Oklahoma City, OK United States

Steven Ramael, MD

Research Site
Philadelphia, PA United States

Steven Ramael, MD

Research Site
Charlottesville, VA United States

Kendra Campbell

Research Site 056
Anniston, AL United States

Karen Hung

Research Site 057
Valley Village, CA United States

Diamond Austin

Research Site 055
Elkridge, MD United States

Tara Hope Hensley

Research Site 059
Kingsport, TN United States

Janeth Castaneda

Research Site 054
Houston, TX United States

Stephen Devenport

Research Site 049
Riverton, UT United States