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Investigation Of The Effect Of Steady State Filibuvir On The Pharmacokinetics Of Oral Contraceptives (Levonorgestrel And Ethinyl Estradiol)

Last updated on March 15, 2019

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Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatitis C
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy female subjects between the ages of 18 and 45 years, inclusive (Healthy is
defined as no clinically relevant abnormalities identified by a detailed medical
history, full physical examination, including blood pressure and pulse rate
measurement, 12-lead ECG and clinical laboratory tests).

- Subjects must have been on any combination of ethinyl estradiol and levonorgesterol
oral contraceptives for at least one consecutive month prior to Period 1.

- Body Mass Index (BMI) of approximately 17.5 to 30.5 kg/m2; and a total body weight >45
kg.

- Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the trial.

- Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other trial procedures.

- Must be willing to practice an alternative method of contraception for the duration of
the study in addition to oral contraceptive use.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- Any medical reason which would contraindicate the administration of oral
contraceptives (as per label). Including but not limited to history of unexplained
vaginal bleeding, current breast cancer, active liver disease, uncontrolled
hypertension, history of diabetes with vascular complications, history of venous
thrombosis, stroke, ischemic heart disease, history of severe headaches with focal
neurologic symptoms.

- Female subjects of non-childbearing potential who meet the following criteria:

- Post menopausal, aged between 45-55 who have been amenorrheic for >2 years and who
meet the criteria for serum FSH levels (>30 IU/L), or

- Females who have undergone a hysterectomy, or

- Females who have undergone tubal ligation, or

- Females who have undergone bilateral oophorectomy.

- History of discontinued use of oral contraceptives for medical reasons.

- History of febrile illness within 5 days prior to the first dose.

- Any condition possibly affecting drug absorption (eg, gastrectomy).

NCT00918476
Pfizer
Completed
Investigation Of The Effect Of Steady State Filibuvir On The Pharmacokinetics Of Oral Contraceptives (Levonorgestrel And Ethinyl Estradiol)

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