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Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants

NCT07762287 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-13

No results posted yet for this study

Summary

This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones. The researchers want to find out whether a new tablet form of elinzanetant is absorbed and processed by the body of healthy women in a similar way than an existing capsule form.

About 100 healthy women aged 18 to 65 will take part in this study. Each participant will receive both forms of the medicine at different times during the study. They will take the medicine once daily for several days under controlled conditions at a study center, and blood samples will be collected to measure how the body absorbs and handles the drug. The study is designed so that each participant can be compared to herself, helping researchers clearly understand any differences between the two formulations.

Conditions

  • Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women

Interventions

DRUG

Elinzanetant (BAY 3427080) treatment A

Elinzanetant treatment A is administered orally once daily.

DRUG

Elinzanetant (BAY 3427080) treatment B

Elinzanetant treatment B is administered orally once daily.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-22
Primary Completion
2027-02-22
Completion
2027-02-22

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07762287 on ClinicalTrials.gov