check_circleStudy Completed

Biological availability

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

Female

Age

45 - 70 Years

Trial summary

Enrollment Goal
68
Trial Dates
November 2017 - February 2019
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1902607
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Mönchengladbach GmbHMönchengladbach, 41061, Germany
Completed
CRS Clinical-Research-Services Mannheim GmbHMannheim, 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 RIF
    date_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 RIF
    date_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 RIF
    date_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 RIF
    date_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 RIF
    date_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 RIF
    date_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 RIF
    date_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 RIF
    date_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 RIF
    date_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 RIF
    date_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 RIF
    date_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 RIF
    date_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 RIF
    date_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 RIF
    date_rangeTime Frame:
    Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3

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