Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT03353857
Eligibility Criteria:
Inclusion Criteria:
* Healthy female subject based on a complete medical history, physical examination, ECG, and clinical laboratory tests
* Age: 45 to 70 years (inclusive) at the first screening visit
* Minimum body weight 50 kg with Body mass index (BMI) above or equal to 18.5 kg/m², and below or equal to 30 kg/m² at the first screening visit
* Postmenopausal state, revealed indicated by either:
* medical history, if applicable (natural menopause at least 12 months prior to first study drug administration, for women younger than 60 years confirmed by follicle stimulating hormone (FSH) \>40 IU/L AND estradiol ≤ 20 pg/mL; or
* surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administration)
Exclusion Criteria:
* Relevant diseases within the last 4 weeks prior to the first study drug administration, i.e. any disease requiring treatment by a health-care provider
* Febrile illness within 1 week before the first study drug administration
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Presence or history of thrombosis, thrombophlebitis, thromboembolic diseases of veins and/or arteries, e.g. deep vein thrombosis, stroke, myocardial infarction, pulmonary embolism, transient ischemic attack, angina pectoris
* Presence or history of conditions that increase the risk of thromboembolic diseases, e.g. disturbances of the coagulation system, thromboembolic diseases in close relatives at age ≤50 years\], valvular heart disease, atrial fibrillation, cardiac dysfunction)
* Presence, history, or suspected presence of malignant tumors or tumors of the liver and pituitary
* Presence or history of liver disease e.g. disturbances of the bilirubin excretion (Dubin-Johnson and Rotor syndromes), cholecystectomy ; cholestasis, idiopathic icterus or pruritus during a previous pregnancy or estrogen-progestogen treatment
* Relevant kidney diseases or renal injury associated with multisystem diseases/disorders, e.g. glomerulonephritis systemic lupus erythematous, diabetic nephropathy. A history of a single episode of uncomplicated nephrolithiasis does not prevent participation
* Known metabolic disorder, e.g. diabetes mellitus, severe hypertriglyceridemia
* Migraine with neurologic symptoms
* Clinically significant depression, current or in the last year
* Known current thyroid disorders which require treatment. Subjects with an euthyroid struma who do not need any treatment can participate.
* Chronic respiratory insufficiency
* History of porphyria
* Contraindications for midazolam, e.g. myasthenia gravis, and sleep apnea
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT03353857
Study Brief:
Protocol Section:
NCT03353857