NCT03596762

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_2

Geographic Reach
3 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 20, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2019

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

March 10, 2023

Completed
Last Updated

March 10, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

July 12, 2018

Results QC Date

November 14, 2022

Last Update Submit

February 10, 2023

Conditions

MenopauseHot FlashesNight Waking

Outcome Measures

Primary Outcomes (4)

  • Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4

    Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity.

    From baseline to Week 4

  • Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12

    Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity.

    From baseline to Week 12

  • Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4

    Participants recorded daily in their eDiary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).

    From baseline to Week 4

  • Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12

    Participants recorded daily in their eDiary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). Severity was graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).

    From baseline to Week 12

Secondary Outcomes (53)

  • Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16

    From baseline to Weeks 1, 2, 8 and 16

  • Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16

    From baseline to Weeks 1, 2, 8 and 16

  • Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16

    From baseline to Weeks 1, 2, 4, 8, 12 and 16

  • Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16

    From baseline to Weeks 1, 2, 4, 8, 12 and 16

  • Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16

    From baseline to Weeks 1, 2, 4, 8, 12 and 16

  • +48 more secondary outcomes

Study Arms (5)

160 mg Elinzanetant (BAY3427080)

EXPERIMENTAL

Participants received 4x40 mg elinzanetant capsules.

Drug: Elinzanetant (BAY3427080)

120 mg Elinzanetant (BAY3427080)

EXPERIMENTAL

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

Drug: Elinzanetant (BAY3427080)

80 mg Elinzanetant (BAY3427080)

EXPERIMENTAL

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

Drug: Elinzanetant (BAY3427080)

40 mg Elinzanetant (BAY3427080)

EXPERIMENTAL

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

Drug: Elinzanetant (BAY3427080)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Elinzanetant (BAY3427080)DRUG

BAY3427080 capsules

Also known as: NT-814
120 mg Elinzanetant (BAY3427080)160 mg Elinzanetant (BAY3427080)40 mg Elinzanetant (BAY3427080)80 mg Elinzanetant (BAY3427080)
PlaceboDRUG

Placebo capsules

Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal
  • Body mass index between 18 and 38 kg/m2, inclusive
  • Subject experiences moderate or severe hot flashes

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Study Site 12

Mesa, Arizona, 85209, United States

Location

Study Site 19

San Diego, California, 92108, United States

Location

Study Site 13

Aventura, Florida, 33180, United States

Location

Study Site 15

Lake Worth, Florida, 33461, United States

Location

Study Site 18

Atlanta, Georgia, 30328, United States

Location

Study Site 16

New Orleans, Louisiana, 70125, United States

Location

Study Site 10

Boston, Massachusetts, 02114, United States

Location

Study Site 11

Boston, Massachusetts, 02115, United States

Location

Study Site 17

Las Vegas, Nevada, 89128, United States

Location

Study Site 14

Houston, Texas, 77054, United States

Location

Study Site 50

Red Deer, Alberta, Canada

Location

Study Site 51

Mission, British Columbia, Canada

Location

Study Site 54

Guelph, Ontario, Canada

Location

Study Site 52

Scarborough Village, Ontario, Canada

Location

Study Site 53

Toronto, Ontario, Canada

Location

Study Site 37

Blackpool, United Kingdom

Location

Study Site 34

Cannock, United Kingdom

Location

Study Site 31

Glasgow, United Kingdom

Location

Study Site 39

Leeds, United Kingdom

Location

Study Site 38

Liverpool, United Kingdom

Location

Study Site 30

London, United Kingdom

Location

Study Site 36

Manchester, United Kingdom

Location

Study Site 33

Poole, United Kingdom

Location

Study Site 32

Southport, United Kingdom

Location

Study Site 35

Stockton-on-Tees, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Therapeutic Area Head
Organization
Bayer AG
clinical-trials-contact@bayer.com
1-888-8422937

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2018

First Posted

July 24, 2018

Study Start

November 20, 2018

Primary Completion

November 21, 2019

Study Completion

November 21, 2019

Last Updated

March 10, 2023

Results First Posted

March 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Locations

CA(5)GB(10)US(10)