Status:
COMPLETED
Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam
Lead Sponsor:
Bayer
Conditions:
Biological Availability
Eligibility:
FEMALE
45-70 years
Phase:
PHASE1
Brief Summary
Quantify the effect of a probe CYP3A4 inducer (Rifampicin) on the pharmacokinetics of levonorgestrel, norethindrone, desogestrel, dienogest, drospirenone,estradiol and midazolam
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2019
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03353857
Start Date
November 29 2017
End Date
February 19 2019
Last Update
April 15 2020
Active Locations (2)
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1
CRS Clinical-Research-Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany, 68167
2
CRS Clinical-Research-Services Mönchengladbach GmbH
Mönchengladbach, North Rhine-Westphalia, Germany, 41061