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

• Status: Completed
• Trial end date: 2019-11-21
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer; Nerre Therapeutics Ltd.
• Collaborator: Nerre Therapeutics Ltd.

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.