Biological Availability Clinical Trial
Official title:
Open-label, Randomized, Fixed Sequence Cross-over Study With Five Parallel Treatment Arms and Three Treatment Periods to Quantify the Drug-drug Interactions of Two Rifampicin Dose Strengths on Four Progestins and a Fixed Progestin-ethinylestradiol Combination Compared With Midazolam in Healthy Post-menopausal Women
Verified date | April 2020 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Quantify the effect of a probe CYP3A4 inducer (Rifampicin) on the pharmacokinetics of levonorgestrel, norethindrone, desogestrel, dienogest, drospirenone,estradiol and midazolam
Status | Completed |
Enrollment | 68 |
Est. completion date | February 19, 2019 |
Est. primary completion date | July 4, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 45 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | CRS Clinical-Research-Services Mannheim GmbH | Mannheim | Baden-Württemberg |
Germany | CRS Clinical-Research-Services Mönchengladbach GmbH | Mönchengladbach | Nordrhein-Westfalen |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the plasma concentration time curve from zero to infinity (AUC) of levonorgestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF | Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3 | ||
Primary | Maximum plasma concentration (Cmax) of levonorgestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF | Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3 | ||
Primary | Area under the plasma concentration time curve from zero to infinity (AUC) of norethindrone in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF | Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3 | ||
Primary | Maximum plasma concentration (Cmax) of norethindrone in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF | Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3 | ||
Primary | Area under the plasma concentration time curve from zero to infinity (AUC) of etonogestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF | Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3 | ||
Primary | Maximum plasma concentration (Cmax) of etonogestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF | Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3 | ||
Primary | Area under the plasma concentration time curve from zero to infinity (AUC) of dienogest in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF | Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3 | ||
Primary | Maximum plasma concentration (Cmax) of dienogest in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF | Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3 | ||
Primary | Area under the plasma concentration time curve from zero to infinity (AUC) of drospirenone (+EE) in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF | Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3 | ||
Primary | Maximum plasma concentration (Cmax) of drospirenone (+EE) in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF | Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3 | ||
Primary | Area under the plasma concentration time curve from zero to infinity (AUC) of ethinylestradiol (+DRSP) in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF | Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3 | ||
Primary | Maximum plasma concentration (Cmax) of ethinylestradiol (+DRSP) in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF | Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3 | ||
Primary | Area under the plasma concentration time curve from zero to infinity (AUC) of midazolam in combination with the hormonal contraceptive only (without RIF) and in combination with 10 mg/d and 600 mg/d RIF | Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3 | ||
Primary | Maximum plasma concentration (Cmax) of midazolam in combination with the hormonal contraceptive only (without RIF) and in combination with 10 mg/d and 600 mg/d RIF | Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3 |
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