Trial Condition(s):

Biological Availability

Drug-drug interaction between rifampicin and progestins/ethinylestradiol and midazolam

Bayer Identifier:

19604

ClinicalTrials.gov Identifier:

NCT03353857

EudraCT Number:

2017-002792-26

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
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Phase
1
Could I receive a placebo?
No
Products
BAY1902607
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical-Research-Services Mönchengladbach GmbH

Mönchengladbach, Germany, 41061

Status
Completed
 
Locations

CRS Clinical-Research-Services Mannheim GmbH

Mannheim, Germany, 68167

Status
Completed
 

Trial Design