Study Details

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A dose-ranging study of the efficacy of ESN364 in postmenopausal women suffering vasomotor symptoms (hot flashes)

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT03192176

Astellas Study ID

The unique identification code given by the study sponsor.

ESN364_HF_205

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Follow Trial

Condition

Menopause, Hot Flashes

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

40 years - 65 years

Sex

Female

Product

fezolinetant

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jul 2017 - Sep 2018

Masking

Triple (Participant, Investigator, Outcomes Assessor)

Enrollment number

356

A Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging, Phase 2b Study to Investigate the Efficacy of ESN364 in Postmenopausal Women Suffering from Vasomotor Symptoms (Hot Flashes)

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Research Site

Vienna, United States, 22182

Research Site

Ormond Beach, United States, 32174

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Mount Pleasant, United States, 29464

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Norfolk, United States, 68701

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Elkridge, United States, 21075

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Atlanta, United States, 30312

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Anniston, United States, 36207

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San Antonio, United States, 78229

Research Site 058

Sacramento, United States, 95821

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Houston, United States, 77058

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Birmingham, United States, 35205

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Spokane, United States, 99207

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Champaign, United States, 61820

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Philadelphia, United States, 19140

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Cleveland, United States, 44122

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Jupiter, United States, 33458

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Riverton, United States, 84065

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Clarksville, United States, 37040

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Lake Worth, United States, 33461

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Marrero, United States, 70072

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DeLand, United States, 32720

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Hurst, United States, 76054

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Watertown, United States, 02472

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Columbus, United States, 43213

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Port Saint Lucie, United States, 34952

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Charlottesville, United States, 22911

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Valley Village, United States, 91607

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Columbus, United States, 43210

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Seattle, United States, 98105

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Williamsville, United States, 14221

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Denver, United States, 80209

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Lincoln, United States, 68510

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Lampasas, United States, 76550

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Kingsport, United States, 37660

Research Site 052

Sacramento, United States, 95821

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New York, United States, 10032

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Cincinnati, United States, 45267

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Miami, United States, 33144

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Thousand Oaks, United States, 91360

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Plano, United States, 75093

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Norcross, United States, 30092

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Milford, United States, 06460

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San Diego, United States, 92114

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Las Vegas, United States, 89123

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Panorama City, United States, 91402

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Los Angeles, United States, 90057

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Oklahoma City, United States, 73112

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Meridian, United States, 83642

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Oceanside, United States, 92056

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Phoenix, United States, 85023

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Crystal River, United States, 34429

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