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:
EudraCT Number:
EU CT Number:
Not Available
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 flashesExclusion 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Study Site 12 Mesa, United States, 85209 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 19 San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 13 Aventura, United States, 33180 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 15 Lake Worth, United States, 33461 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 18 Atlanta, United States, 30328 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 16 New Orleans, United States, 70125 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 10 Boston, United States, 02114 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 11 Boston, United States, 02115 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 17 Las Vegas, United States, 89128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 14 Houston, United States, 77054 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 50 Red Deer, Canada | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 51 Mission, Canada | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 54 Guelph, Canada | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 52 Scarborough, Canada | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 53 Toronto, Canada | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 37 Blackpool, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 34 Cannock, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 31 Glasgow, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 39 Leeds, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 38 Liverpool, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 30 London, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 36 Manchester, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 33 Poole, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 32 Southport, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Study Site 35 Stockton-on-Tees, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
Primary Outcome
- Mean change from baseline in frequency of moderate and severe hot flashes recorded in patient diaryTimeframe: Week 4
- Mean change from baseline in frequency of moderate and severe hot flashes recorded in patient diaryTimeframe: Week 12
- Mean change from baseline in severity of moderate and severe hot flashes recorded in patient diaryTimeframe: Week 4
- Mean change from baseline in severity of moderate and severe hot flashes recorded in patient diaryTimeframe: Week 12
Additional Information
Not Available
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