Trial Condition(s):

Menopause, Hot Flashes, Night Waking

A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms (SWITCH-1)

Bayer Identifier:

21686

ClinicalTrials.gov Identifier:

NCT03596762

EudraCT Number:

2018-002763-26

Study Completed

Trial Purpose

The purpose of this study is to determine the effectiveness of BAY3427080 (NT-814), taken once a day, in the treatment of troublesome post-menopausal symptoms.

Inclusion Criteria
-  Postmenopausal

          -  Body mass index between 18 and 38 kg/m2, inclusive

          -  Subject experiences moderate or severe hot flashes
Exclusion Criteria
-  Inability to comply with the use of prohibited and allowed medications as described in the protocol.

          -  Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12 months of Screening.

          -  Any clinically significant prior or ongoing history of arrhythmias, either determined through clinical history or on ECG evaluation.

          -  Any clinically significant abnormal laboratory test result(s) measured at Screening.

          -  Any active ongoing condition that could have caused difficulty in interpreting vasomotor symptoms.

          -  Uncontrolled hypertension.

          -  A history or hyperthyroidism, hypothyroidism or abnormal thyroid function tests at Screening. Treated hypothyroidism with normal thyroid function test results at  Screening is acceptable.

Trial Summary

Enrollment Goal
199
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
BAY3427080
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Study Site 12

Mesa, United States, 85209

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Study Site 19

San Diego, United States, 92108

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Study Site 13

Aventura, United States, 33180

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Study Site 15

Lake Worth, United States, 33461

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Study Site 18

Atlanta, United States, 30328

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Study Site 16

New Orleans, United States, 70125

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Study Site 10

Boston, United States, 02114

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Study Site 11

Boston, United States, 02115

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Study Site 17

Las Vegas, United States, 89128

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Study Site 14

Houston, United States, 77054

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Study Site 50

Red Deer, Canada

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Study Site 51

Mission, Canada

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Study Site 54

Guelph, Canada

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Study Site 52

Scarborough, Canada

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Study Site 53

Toronto, Canada

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Study Site 37

Blackpool, United Kingdom

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Study Site 34

Cannock, United Kingdom

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Study Site 31

Glasgow, United Kingdom

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Study Site 39

Leeds, United Kingdom

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Study Site 38

Liverpool, United Kingdom

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Study Site 30

London, United Kingdom

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Study Site 36

Manchester, United Kingdom

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Study Site 33

Poole, United Kingdom

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Study Site 32

Southport, United Kingdom

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Study Site 35

Stockton-on-Tees, United Kingdom

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Trial Design