Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel

Boehringer Ingelheim

Status and phase

Terminated

Phase 1

Conditions

Healthy

Treatments

Drug: Microgynon®

Drug: faldaprevir

Drug: BI 207127

Study type

Interventional

Funder types

Industry

Identifiers

NCT01941615

2013-000298-62 (EudraCT Number)

1241.31

Details and patient eligibility

About

Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in healthy premenopausal female volunteers.

Enrollment

18 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy female subjects
Age 18 to 35 years (inclusive)
Body Mass Index 20-29.9 kg/m2
Use of hormonal contraception (i.e. oral contraceptives, hormonal contraceptive vaginal ring, but not hormone-containing intrauterine devices, depot injections or contraceptive implants)

Exclusion criteria

Any relevant deviation from healthy conditions
Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
Positive pregnancy test, pregnancy or planning to become pregnant within 1 month of study completion, or lactation
Any relevant finding of the gynaecological examination
Thrombotic predisposition according to thrombophilic testing
Existing or history of arterial thrombotic or embolic processes, conditions which predispose to them e.g. disorders of the clotting processes, valvular heart disease and atrial fibrillation
Existing or history of confirmed venous thromboembolism, family history of venous thromboembolism, and other known risk factors for venous thromboembolism.
Relevant varicosis
No use of an additional contraceptive method from screening examination until 1 month after last study drug administration (acceptable methods are considered to be barrier methods, sexual abstinence, non-hormone-containing intrauterine device, or vasectomisation for the male partner).

Use of hormone-containing intrauterine device, depot injection or contraceptive implants

Any history of relevant liver diseases (e.g. disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, or previous or existing liver tumours)
AST (aspartate transaminase) and/or ALT (alanine transaminase) > 1.5 ULN (upper limit of normal)