check_circleStudy Completed

Vasomotor Symptoms as a sex-hormone dependent disorder in women and men

Bayer Identifier:

21665

ClinicalTrials.gov Identifier:

NCT04845841

EudraCT Number:

2020-005715-49

EU CT Number:

Not Available
Comparison of the extent to which the drug given as two different capsule sizes becomes available to the body

Trial purpose

Researchers are looking for a new way to treat women who have symptoms by hormonal changes, like those that happen in women during menopause. These symptoms can include hot flashes, night sweats, and changes in blood pressure. These symptoms are caused by hormonal changes occurring during menopausal transition when women may have also changes in their monthly cycles. The menopausal transition most often begins between ages 45 and 55 and leads to menopause, a point in time 12 months after a woman's last period.
The study drug, elinzanetant, was designed to treat symptoms caused by hormonal changes. Before a new treatment can be approved for people to take, researchers perform clinical trials to better understand how this treatment works and to investigate safety.
The purpose of this study is to assess the blood levels of elinzanetant when given as 2 capsules of dose A (what is intended for further research and future commercialization) and also to compare the blood levels when given as 3 capsules of dose B (what was used for research up to now). Furthermore, researchers want to find out if taking of elinzanetant on two time points leads to differences in blood levels of elinzanetant.
This trial will be performed in healthy women aged 40 to 65 years.

Key Participants Requirements

Sex

Female

Age

40 - 65 Years
  • - Participant must be 40 to 65 years of age inclusive, at the time of signing the informed consent.
    - Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, blood pressure, pulse rate, 12-lead electrocardiogram, body temperature, and laboratory tests.
    - Non-smoker, at least from 3 months before the screening visit onwards
    - Body weight of at least 50 kg and BMI within the range 18.0 and 30.0 kg/m*2 (inclusive) at screening.
    - Female
     -- Women of childbearing potential will have to use highly effective non-hormonal contraception when having sexual intercourse with a male partner from signing the informed consent form until 5 days after last dose of the study drug. Acceptable methods of contraception for this study are listed in protocol.
     -- Women of non-childbearing potential are not required to use contraception. Non-childbearing potential is defined as
     --- Postmenopausal state confirmed by follicle stimulating hormone (FSH) level >40 U/L, or above reference range from the local laboratory, or
     --- Surgically sterilized by bilateral tubal ligation, or bilateral oophorectomy with or without hysterectomy documented by medical report verification
  • - Pregnant or breastfeeding women.
    - Any clinically relevant abnormal findings in medical history and physical examination which in the opinion of the investigators, may put the participant at risk because of her participation in the trial or provide difficulties in interpreting the trial data.
    - History or evidence of any clinically relevant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other clinically relevant disease, as judged by the investigator.
    - Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.
    - Any medical disorder, condition or history of such that would impair the participant’s ability to participate or complete this study in the opinion of the investigator.
    - Known hypersensitivity to the study interventions (active substances, or excipients of the preparations).
    - Known severe allergies e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract – allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant non-allergic drug reactions.
    - Relevant diseases within the last 4 weeks prior to the first study intervention administration.
    - Febrile illness within 4 weeks before first study intervention administration.
    - Regular use of medicines.

Trial summary

Enrollment Goal
16
Trial Dates
April 2021 - June 2021
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY3427080
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Recruiting
CRS Clinical-Research-Services Mannheim GmbHMannheim, 68167, Germany

Primary Outcome

  • AUC of elinzanetant
    AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose
    date_rangeTime Frame:
    Period 1: Day 1-9, Day 11, Day 13, Day 15; Period 2: Day 1-7, Day 8 (follow up visit)
  • Cmax of elinzanetant
    Cmax: Maximum observed drug concentration in measured matrix after single dose administration
    date_rangeTime Frame:
    Period 1: Day 1-9, Day 11, Day 13, Day 15; Period 2: Day 1-7, Day 8 (follow up visit)

Secondary Outcome

  • Incidence of treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Approximately 2 to 3 months
  • Severity of treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Approximately 2 to 3 months

Trial design

Single center, randomized, open-label, cross-over study to investigate the pharmacokinetics of two oral formulations of elinzanetant after single dosing in healthy participants
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2