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A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms (SWITCH-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03596762
Recruitment Status : Completed
First Posted : July 24, 2018
Last Update Posted : November 18, 2020
Sponsor:
Collaborator:
Nerre Therapeutics Ltd.
Information provided by (Responsible Party):
Bayer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Menopause Hot Flashes Night Waking Drug: BAY3427080 Drug: Placebo Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 20, 2018
Actual Primary Completion Date : November 21, 2019
Actual Study Completion Date : November 21, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: 160 mg BAY3427080 Drug: BAY3427080
BAY3427080 capsules
Other Name: NT-814
Experimental: 120 mg BAY3427080 Drug: BAY3427080
BAY3427080 capsules
Other Name: NT-814
Experimental: 80 mg BAY3427080 Drug: BAY3427080
BAY3427080 capsules
Other Name: NT-814
Experimental: 40 mg BAY3427080 Drug: BAY3427080
BAY3427080 capsules
Other Name: NT-814
Placebo Comparator: Placebo Drug: Placebo
Placebo capsules


Outcome Measures
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Primary Outcome Measures :
  1. Mean change from baseline in frequency of moderate and severe hot flashes recorded in patient diary [ Time Frame: Week 4 ]
  2. Mean change from baseline in frequency of moderate and severe hot flashes recorded in patient diary [ Time Frame: Week 12 ]
  3. Mean change from baseline in severity of moderate and severe hot flashes recorded in patient diary [ Time Frame: Week 4 ]
  4. Mean change from baseline in severity of moderate and severe hot flashes recorded in patient diary [ Time Frame: Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

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

Key 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596762


Locations
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Sponsors and Collaborators
Bayer
Nerre Therapeutics Ltd.
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03596762    
Other Study ID Numbers: 21686
2018-002763-26 ( EudraCT Number )
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hot Flashes