check_circleStudy Completed
Biological availability
Bayer Identifier:
19604
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Drug-drug interaction between rifampicin and progestins/ethinylestradiol and midazolam
Trial purpose
Quantify the effect of a probe CYP3A4 inducer (Rifampicin) on the pharmacokinetics of levonorgestrel, norethindrone, desogestrel, dienogest, drospirenone,estradiol and midazolam
Key Participants Requirements
Sex
FemaleAge
45 - 70 YearsTrial summary
Enrollment Goal
68Trial Dates
November 2017 - February 2019Phase
Phase 1Could I Receive a placebo
NoProducts
BAY1902607Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | CRS Clinical-Research-Services Mönchengladbach GmbH | Mönchengladbach, 41061, Germany |
Completed | CRS Clinical-Research-Services Mannheim GmbH | Mannheim, 68167, Germany |
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 RIFdate_rangeTime Frame: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 RIFdate_rangeTime Frame: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 RIFdate_rangeTime Frame: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 RIFdate_rangeTime Frame: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 RIFdate_rangeTime Frame: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 RIFdate_rangeTime Frame: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 RIFdate_rangeTime Frame: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 RIFdate_rangeTime Frame: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 RIFdate_rangeTime Frame: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 RIFdate_rangeTime Frame: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 RIFdate_rangeTime Frame: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 RIFdate_rangeTime Frame: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 RIFdate_rangeTime Frame: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 RIFdate_rangeTime Frame:Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
5