CompletedPhase 1

Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body

Germany16 participantsStarted 2021-04-09

Plain-language summary

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.

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 partici…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

AUC of elinzanetant

Timeframe: Period 1: Day 1-9, Day 11, Day 13, Day 15; Period 2: Day 1-7, Day 8 (follow up visit)

Cmax of elinzanetant

Timeframe: Period 1: Day 1-9, Day 11, Day 13, Day 15; Period 2: Day 1-7, Day 8 (follow up visit)

Trial details

NCT IDNCT04845841

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-01

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