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Drug-drug Interaction of BI 201335 and Microgynon

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01570244
First Posted: April 4, 2012
Last Update Posted: August 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
This study will investigate possible effect of multiple oral doses of BI 201335 on the steady state pharmacokinetics of ethinylestradiol and levonogestrel

Condition Intervention Phase
Hepatitis C, Chronic Drug: levonorgestrel Drug: Ethinylestradiol Drug: BI 201335 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Two-period, Fixed-sequence, Phase I Trial to Evaluate the Effect of Multiple Doses of 240 mg BI 201335 QD on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Volunteers

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • AUCt,ss of Ethinylestradiol [ Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 hours (h) after drug administration ]
    Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol

  • Cmax,ss of Ethinylestradiol [ Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration ]
    maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol

  • C24,ss of Ethinylestradiol [ Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration ]
    measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol

  • AUCτ,ss of Levonorgestrel [ Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration ]
    Area under the curve over the dosing interval τ under steady state conditions of levonorgestrel

  • Cmax,ss of Levonorgestrel [ Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration ]
    maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel

  • C24,ss of Levonorgestrel [ Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration ]
    measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel


Secondary Outcome Measures:
  • Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. [ Time Frame: from drug administration up to 14 days ]
    Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

  • Number of Participants With Drug Related Adverse Events [ Time Frame: from drug administration up to 14 days ]
    number of participants with investigator-defined drug related adverse events


Enrollment: 16
Study Start Date: April 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reference
multiple doses of Microgynon
Drug: levonorgestrel
multiple doses
Drug: Ethinylestradiol
multiple doses
Active Comparator: Test
multiple doses of Microgynon + BI 201335
Drug: levonorgestrel
multiple doses
Drug: Ethinylestradiol
multiple doses
Drug: BI 201335
multiple doses

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570244


Locations
Germany
1220.56.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01570244     History of Changes
Other Study ID Numbers: 1220.56
2011-006061-17 ( EudraCT Number: EudraCT )
First Submitted: April 2, 2012
First Posted: April 4, 2012
Results First Submitted: July 3, 2015
Results First Posted: August 3, 2015
Last Update Posted: August 3, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Ethinyl Estradiol-Norgestrel Combination
Ethinyl Estradiol
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Combined
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital