check_circleStudy Completed

Menopause, Hot Flashes, Night Waking

Bayer Identifier:

21686

ClinicalTrials.gov Identifier:

NCT03596762

EudraCT Number:

2018-002763-26

EU CT Number:

Not Available
A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms

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.

Key Participants Requirements

Sex

Female

Age

40 - 65 Years
  • Key :

    - Postmenopausal

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

    - Subject experiences moderate or severe hot flashes

    Key
  • - 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
November 2018 - November 2019
Phase
Phase 2
Could I Receive a placebo
Yes
Products
BAY3427080
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Study Site 12Mesa, 85209, United States
Study Site 19San Diego, 92108, United States
Study Site 13Aventura, 33180, United States
Study Site 15Lake Worth, 33461, United States
Study Site 18Atlanta, 30328, United States
Study Site 16New Orleans, 70125, United States
Study Site 10Boston, 02114, United States
Study Site 11Boston, 02115, United States
Study Site 17Las Vegas, 89128, United States
Study Site 14Houston, 77054, United States
Study Site 50Red Deer, Canada
Study Site 51Mission, Canada
Study Site 54Guelph, Canada
Study Site 52Scarborough, Canada
Study Site 53Toronto, Canada
Study Site 37Blackpool, United Kingdom
Study Site 34Cannock, United Kingdom
Study Site 31Glasgow, United Kingdom
Study Site 39Leeds, United Kingdom
Study Site 38Liverpool, United Kingdom
Study Site 30London, United Kingdom
Study Site 36Manchester, United Kingdom
Study Site 33Poole, United Kingdom
Study Site 32Southport, United Kingdom
Study Site 35Stockton-on-Tees, United Kingdom

Primary Outcome

  • Mean change from baseline in frequency of moderate and severe hot flashes recorded in patient diary
    date_rangeTime Frame:
    Week 4
  • Mean change from baseline in frequency of moderate and severe hot flashes recorded in patient diary
    date_rangeTime Frame:
    Week 12
  • Mean change from baseline in severity of moderate and severe hot flashes recorded in patient diary
    date_rangeTime Frame:
    Week 4
  • Mean change from baseline in severity of moderate and severe hot flashes recorded in patient diary
    date_rangeTime Frame:
    Week 12

Trial design

A Double-Blind, Randomised, Placebo Controlled, Adaptive Design Study of the Efficacy, Safety and Pharmacokinetics of NT-814 in Female Subjects With Moderate to Severe Vasomotor Symptoms Associated With the Menopause
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
5