Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms (RELENT-1)

Bayer

Status and phase: Completed; Phase 2; Phase 1

Conditions: Post-menopausal Vasomotor Symptoms

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02865538

21681

Details and patient eligibility

About

This is a multi-center, double-blind, randomized, placebo-controlled multiple ascending dose study in post-menopausal women with vasomotor symptoms. Single ascending doses of NT-814 will be investigated in 4 cohorts. Each cohort will comprise of 20 subjects. Subjects will be dosed for 14 days.

Enrollment: 76 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Post-menopausal female subjects experiencing frequent moderate to severe hot flashes.Menopause will be defined as:

  • 12 months of spontaneous amenorrhea;
  • OR at least 6 weeks' post-surgical bilateral oophorectomy with or without hysterectomy.

Exclusion criteria

• BMI > 35kg/m2.
• Any active comorbid disease, ECG or laboratory result deemed by the investigator to be clinically significant and which could impact safety during study conduct or that could interfere with the study evaluation, procedures or completion.
• Use of prohibited medications defined in the protocol.
• Inability or unwillingness to comply with study procedures or requirements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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76 participants in 5 patient groups, including a placebo group

BAY3427080 Placebo

Placebo Comparator group

Treatment:

Drug: Placebo (for BAY3427080)

50mg BAY3427080

Experimental group

Treatment:

Drug: BAY3427080

100mg BAY3427080

Experimental group

Treatment:

Drug: BAY3427080

150mg BAY3427080

Experimental group

Treatment:

Drug: BAY3427080

300mg BAY3427080

Experimental group

Treatment:

Drug: BAY3427080