Trial Condition(s):
Biological Availability
Drug-drug interaction between rifampicin and progestins/ethinylestradiol and midazolam
Bayer Identifier:
19604
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study Completed
Trial Purpose
Quantify the effect of a probe CYP3A4 inducer (Rifampicin) on the pharmacokinetics of levonorgestrel, norethindrone, desogestrel, dienogest, drospirenone,estradiol and midazolam
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
Trial Summary
Enrollment Goal
68
Trial Dates
Phase
1
Could I receive a placebo?
No
Products
BAY1902607
Accepts Healthy Volunteers
Yes
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations CRS Clinical-Research-Services Mönchengladbach GmbH Mönchengladbach, Germany, 41061 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CRS Clinical-Research-Services Mannheim GmbH Mannheim, Germany, 68167 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
5
Primary Outcome
- 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 RIFTimeframe: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
- Maximum plasma concentration (Cmax) of levonorgestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIFTimeframe: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
- 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 RIFTimeframe: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
- Maximum plasma concentration (Cmax) of norethindrone in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIFTimeframe: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
- 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 RIFTimeframe: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
- Maximum plasma concentration (Cmax) of etonogestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIFTimeframe: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
- 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 RIFTimeframe: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
- Maximum plasma concentration (Cmax) of dienogest in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIFTimeframe: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
- 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 RIFTimeframe: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
- 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 RIFTimeframe: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
- 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 RIFTimeframe: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
- 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 RIFTimeframe: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
- 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 RIFTimeframe: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
- 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 RIFTimeframe: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Additional Information
Copyright © Bayer
Powered by
