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

NCT01328184 | Completed Phase 1 Results

• 2 other identifiers: 1245.412010-023432-16
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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®).

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

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

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

  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.

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

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

  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.

• Ethinylestradiol: Maximum Measured Concentration (Cmax,ss)

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

  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.

• Levonorgestrel: Maximum Measured Concentration (Cmax,ss)

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

  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.

Secondary Outcomes (14)

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

  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.

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

  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.

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

  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.

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

  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.

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

  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.

Study Arms (2)

Reference

EXPERIMENTAL

multiple doses of Microgynon

Drug: levonorgestrel; Drug: Ethinylestradiol

Test

ACTIVE COMPARATOR

multiple doses of Microgynon + BI 10773

Drug: levonorgestrel; Drug: Ethinylestradiol; Drug: Microgynon + BI 10773

Interventions

levonorgestrel DRUG

multiple doses

Reference

Ethinylestradiol DRUG

multiple doses

Test

Microgynon + BI 10773 DRUG

multiple doses BI 10773

Test

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy female subjects

You may not qualify if:

• \. Any relevant deviation from healthy conditions

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1245.41.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Related Publications (1)

• Macha S, Mattheus M, Pinnetti S, Woerle HJ, Broedl UC. Effect of empagliflozin on the steady-state pharmacokinetics of ethinylestradiol and levonorgestrel in healthy female volunteers. Clin Drug Investig. 2013 May;33(5):351-7. doi: 10.1007/s40261-013-0068-y.

  PMID: 23512637 DERIVED

MeSH Terms

Interventions

Levonorgestrel; Ethinyl Estradiol; ethinyl estradiol, levonorgestrel drug combination; empagliflozin

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norpregnatrienes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 4, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2011
• Last Updated: June 18, 2014
• Results First Posted: June 18, 2014

Record last verified: 2014-05

Locations

DE (1)