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OpenTrials
Completed

NCT Number: NCT01328184

Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon

The objective of this study is to investigate the possible effect of multiple oral doses of 25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (Microgynon®).

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Key information

Conditions

Healthy

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

1245.41.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy female subjects

Exclusion criteria

  • Any relevant deviation from healthy conditions

Treatment and study plan

Levonorgestrel

Drug

multiple doses

Ethinylestradiol

Drug

multiple doses

Microgynon + BI 10773

Drug

multiple doses BI 10773

Primary outcomes

  1. Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Area under the concentration-time curve of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.

  2. Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Area under the concentration-time curve of levonorgestrel in plasma at steady state over the uniform dosing interval τ.

  3. Ethinylestradiol: Maximum Measured Concentration (Cmax,ss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Maximum measured concentration of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.

  4. Levonorgestrel: Maximum Measured Concentration (Cmax,ss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Maximum measured concentration of levonorgestrel in plasma at steady state over the uniform dosing interval τ.

Secondary outcomes

  1. Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Time from last dosing to the maximum measured concentration of ethinylestradiol in plasma at steady state

  2. Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Time from last dosing to the maximum measured concentration of levonorgestrel in plasma at steady state

  3. Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Apparent clearance of ethinylestradiol in the plasma at steady state after oral administration

  4. Levonorgestrel: Apparent Clearance at Steady State (CL/Fss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Apparent clearance of levonorgestrel in the plasma at steady state after oral administration

  5. Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Apparent volume of distribution during the terminal phase at steady state after oral administration

  6. Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Apparent volume of distribution during the terminal phase at steady state after oral administration

  7. Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Terminal half-life of ethinylestradiol in plasma at steady state

  8. Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Terminal half-life of levonorgestrel in plasma at steady state

  9. Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Terminal rate constant of ethinylestradiol in plasma at steady state

  10. Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Terminal rate constant of levonorgestrel in plasma at steady state

  11. Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Mean residence time of ethinylestradiol in the body at steady state after oral administration

  12. Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss)

    Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

    Mean residence time of levonorgestrel in the body at steady state after oral administration

  13. Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests.

    Time frame: Day 1 to day 17

    Number of participants with clinically relevant abnormalities in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as adverse events.

  14. Assessment of Tolerability

    Time frame: Within Day 24 to Day 31

    Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory, bad and not assessable.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Open-label, Two-period, Fixed-sequence Trial to Evaluate the Effect of Multiple Doses of BI 10773 on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Volunteers

Important dates

Study start
2011
Primary completion
2011
First posted
Apr 4, 2011
Registry last updated
Jun 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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