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

NCT ID: NCT03596762

Last Updated: 2023-03-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2019-11-21

Brief Summary

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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.

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Detailed Description

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This is a multi-centre, multi-country, double-blind, randomised, placebo-controlled Phase 2b study. The study will have a single-blind run-in period and will be adaptive with respect to the number of subjects recruited into each dose group. Four doses of BAY3427080 (40 mg once a day, 80 mg once a day, 120 mg once a day and 160 mg once a day) will be investigated and compared to placebo, in five parallel groups. Subjects will participate in the study for a total of approximately 19 weeks, comprising a screening period of 1 week, a 14 week treatment period, and then a final follow up visit 4 weeks after the end of the treatment period. There will be a total of 8 visits whilst participating in the study. Subjects will record their hot flashes in an electronic diary during the screening period to establish eligibility and throughout the study after randomisation.

Conditions

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Menopause Hot Flashes Night Waking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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160 mg Elinzanetant (BAY3427080)

Participants received 4x40 mg elinzanetant capsules.

Group Type EXPERIMENTAL

Elinzanetant (BAY3427080)

Intervention Type DRUG

BAY3427080 capsules

120 mg Elinzanetant (BAY3427080)

Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.

Group Type EXPERIMENTAL

Elinzanetant (BAY3427080)

Intervention Type DRUG

BAY3427080 capsules

80 mg Elinzanetant (BAY3427080)

Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.

Group Type EXPERIMENTAL

Elinzanetant (BAY3427080)

Intervention Type DRUG

BAY3427080 capsules

40 mg Elinzanetant (BAY3427080)

Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.

Group Type EXPERIMENTAL

Elinzanetant (BAY3427080)

Intervention Type DRUG

BAY3427080 capsules

Placebo

Participants received four placebo capsules orally once daily in the evening before bedtime.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules

Interventions

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Elinzanetant (BAY3427080)

BAY3427080 capsules

Intervention Type DRUG

Placebo

Placebo capsules

Intervention Type DRUG

Other Intervention Names

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NT-814

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nerre Therapeutics Ltd.

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Study Site 12

Mesa, Arizona, United States

Site Status

Study Site 19

San Diego, California, United States

Site Status

Study Site 13

Aventura, Florida, United States

Site Status

Study Site 15

Lake Worth, Florida, United States

Site Status

Study Site 18

Atlanta, Georgia, United States

Site Status

Study Site 16

New Orleans, Louisiana, United States

Site Status

Study Site 10

Boston, Massachusetts, United States

Site Status

Study Site 11

Boston, Massachusetts, United States

Site Status

Study Site 17

Las Vegas, Nevada, United States

Site Status

Study Site 14

Houston, Texas, United States

Site Status

Study Site 50

Red Deer, Alberta, Canada

Site Status

Study Site 51

Mission, British Columbia, Canada

Site Status

Study Site 54

Guelph, Ontario, Canada

Site Status

Study Site 52

Scarborough Village, Ontario, Canada

Site Status

Study Site 53

Toronto, Ontario, Canada

Site Status

Study Site 37

Blackpool, , United Kingdom

Site Status

Study Site 34

Cannock, , United Kingdom

Site Status

Study Site 31

Glasgow, , United Kingdom

Site Status

Study Site 39

Leeds, , United Kingdom

Site Status

Study Site 38

Liverpool, , United Kingdom

Site Status

Study Site 30

London, , United Kingdom

Site Status

Study Site 36

Manchester, , United Kingdom

Site Status

Study Site 33

Poole, , United Kingdom

Site Status

Study Site 32

Southport, , United Kingdom

Site Status

Study Site 35

Stockton-on-Tees, , United Kingdom

Site Status

Countries

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United States Canada United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://clinicaltrials.bayer.com/

Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

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2018-002763-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

21686

Identifier Type: -

Identifier Source: org_study_id

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