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

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Bayer
Study ID
NCT03596762
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Elinzanetant (BAY3427080) — DRUG
    BAY3427080 capsules
  • Placebo — DRUG
    Placebo capsules

Study Details

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 Dates

First listed
Jul 24, 2018
Start date
Nov 20, 2018
Status verified
Feb 2023
Primary completion
Nov 21, 2019
Completion
Nov 21, 2019

Study Design

Enrollment
199 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 160 mg Elinzanetant (BAY3427080)
    Participants received 4x40 mg elinzanetant capsules.
  • Experimental: 120 mg Elinzanetant (BAY3427080)
    Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.
  • Experimental: 80 mg Elinzanetant (BAY3427080)
    Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.
  • Experimental: 40 mg Elinzanetant (BAY3427080)
    Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.
  • Placebo Comparator: Placebo
    Participants received four placebo capsules orally once daily in the evening before bedtime.

Primary Outcome Measure

Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 [ Time Frame: From baseline to Week 4 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Study Site 12MesaArizona85209-
Study Site 19San DiegoCalifornia92108-
Study Site 13AventuraFlorida33180-
Study Site 15Lake WorthFlorida33461-
Study Site 18AtlantaGeorgia30328-
Study Site 16New OrleansLouisiana70125-
Study Site 10BostonMassachusetts02114-
Study Site 11BostonMassachusetts02115-
Study Site 17Las VegasNevada89128-
Study Site 14HoustonTexas77054-

Find similar trials in Mesa, AZ

By condition
Menopause
By specialty
Women's healthFertility
By research site
Study· Mesa, AZStudy· San Diego, CAStudy· Aventura, FLStudy· Lake Worth, FLStudy· Atlanta, GAStudy· New Orleans, LA

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