Status:
COMPLETED
Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body
Lead Sponsor:
Bayer
Conditions:
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Eligibility:
FEMALE
40-65 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04845841
Start Date
April 9 2021
End Date
June 1 2021
Last Update
August 9 2023
Active Locations (1)
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1
CRS Clinical-Research-Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany, 68167