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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03353857
Other study ID # 19604
Secondary ID 2017-002792-26
Status Completed
Phase Phase 1
First received
Last updated
Start date November 29, 2017
Est. completion date February 19, 2019

Study information

Verified date April 2020
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Quantify the effect of a probe CYP3A4 inducer (Rifampicin) on the pharmacokinetics of levonorgestrel, norethindrone, desogestrel, dienogest, drospirenone,estradiol and midazolam


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
levonorgestrel/ Microlut
In Period 1, 0.03 mg single dose administered as 1x0.03 mg tablet on Study Day 1, In Period 2, 0.03 mg single dose administered as 1x0.03 mg tablet on Study Day 15 In Period 3, 0.03 mg single dose administered as 1x0.03 mg tablet at Study Day 26
Norethindrone/ Noriday
In Period 1, 0.35 mg single dose administered as 1x0.35 mg tablet on Study Day 1, In Period 2, 0.35 mg single dose administered as 1x0.35 mg tablet on Study Day 15 In Period 3, 0.35 mg single dose administered as 1x0.35 mg tablet at Study Day 26
Desogestrel/ Cerazette
In Period 1, 0.075 mg single dose administered as 1x0.075 mg tablet on Study Day 1, In Period 2, 0.075 mg single dose administered as 1x0.075 mg tablet on Study Day 15 In Period 3, 0.075 mg single dose administered as 1x0.075 mg tablet at Study Day 26
Dienogest/ Visanne
In Period 1, 2 mg single dose administered as 1x2 mg tablet on Study Day 1, In Period 2, 2 mg single dose administered as 1x2 mg tablet on Study Day 15 In Period 3, 2 mg single dose administered as 1x2 mg tablet at Study Day 26
Drospirenone, Ethinylestradiol/ Yasmin
In Period 1, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 1, In Period 2, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 15, In Period 3, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 26,
Midazolam/ Midazolam-ratiopharm
In Period 1, 1 mg single dose administered as 1x0.5 ml oral solution on Study Day 1, In Period 2, 1 mg single dose administered as 1x0.5 ml oral solution on Study Day 15 In Period 3, 1 mg single dose administered as 1x0.5 ml oral solution at Study Day 26
Rifampicin
In period 2, 10 mg (suspension, 0.5 ml) for 11 days at 10 mg/day In period 3, 600 mg (film-coated tablets) for 11 days at 600 mg/day

Locations

Country Name City State
Germany CRS Clinical-Research-Services Mannheim GmbH Mannheim Baden-Württemberg
Germany CRS Clinical-Research-Services Mönchengladbach GmbH Mönchengladbach Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

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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