Text Size

Drug-drug Interaction of BI 201335 and Microgynon

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01570244
First received: April 2, 2012
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • pharmacokinetic interaction (AUCt,ss of ethinylestradiol and levonorgestrel [Area under the curve over the dosing interval t under steady state conditions]) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • pharmacokinetic interaction (Cmax,ss of ethinylestradiol and levonorgestrel [maximum measured concentration over the uniform dosing interval under steady state conditions]) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • C24,ss of ethinylestradiol and levonorgestrel (measured concentration of the analyte at the end of dosing interval under steady state conditions) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with clinically relevant findings in vital signs [ Time Frame: upt to 14 days postdose ] [ Designated as safety issue: Yes ]
  • Number of participants with clinically relevant changes in electrocardiogram results [ Time Frame: upt to 14 days postdose ] [ Designated as safety issue: Yes ]
  • Number of participants with clinically relevant changes from baseline laboratory measurements [ Time Frame: upt to 14 days postdose ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570244

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

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01570244     History of Changes
Other Study ID Numbers: 1220.56, 2011-006061-17
Study First Received: April 2, 2012
Last Updated: April 3, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013