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NCT02865538 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Bayer.

Completed
Registry status
Phase 1
Development phase
76
Enrollment target

NCT02865538: Completed Phase 1 study, sponsored by Bayer.

NCT02865538 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02865538, a Phase 1 study, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 1
Development phase
76 participants
Enrollment target

Study Summary

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.

Primary Outcome

Cmax is the maximum observed plasma concentration of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.

Interventions

  • DRUG BAY3427080
  • DRUG Placebo (for BAY3427080)

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2016-08-01
Est. Completion 2017-03-28
Phase Phase 1
Bayer

591 total trials

What the finished NCT02865538 record still lists

NCT02865538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).

The record links to 0 conditions, and to 2 interventions - of which BAY3427080 is the first listed.

NCT02865538 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02865538 about?

NCT02865538 is a clinical study titled "Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms". 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.

What is the current status of trial NCT02865538?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2016-08-01. Estimated completion is 2017-03-28.

What interventions are being tested in trial NCT02865538?

The interventions under investigation include: BAY3427080 (DRUG), Placebo (for BAY3427080) (DRUG).

Who is sponsoring clinical trial NCT02865538?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02865538's enrollment target sits among peer trials

76 705th of 2000 higher than 1,290 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02865538, the US trial registry maintained by the National Library of Medicine. NCT02865538 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.