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

Bayer

Status and phase: Completed; Phase 2

Conditions: Night Waking; Menopause; Hot Flashes

Treatments: Drug: Placebo; Drug: Elinzanetant (BAY3427080)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03596762

2018-002763-26 (EudraCT Number)

21686

Details and patient eligibility

About

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.

Full 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.

Enrollment: 199 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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199 participants in 5 patient groups, including a placebo group

160 mg Elinzanetant (BAY3427080)

Experimental group

Description:

Participants received 4x40 mg elinzanetant capsules.

Treatment:

Drug: Elinzanetant (BAY3427080)

120 mg Elinzanetant (BAY3427080)

Experimental group

Description:

Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.

Treatment:

Drug: Elinzanetant (BAY3427080)

80 mg Elinzanetant (BAY3427080)

Experimental group

Description:

Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.

Treatment:

Drug: Elinzanetant (BAY3427080)

40 mg Elinzanetant (BAY3427080)

Experimental group

Description:

Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.

Treatment:

Drug: Elinzanetant (BAY3427080)

Placebo

Placebo Comparator group

Description:

Participants received four placebo capsules orally once daily in the evening before bedtime.

Treatment:

Drug: Placebo