Expired Study
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Miami, Florida 33126


The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine SR on the pharmacokinetics of Tamoxifen and endoxifen when coadministered to healthy post-menopausal female subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Tamoxifen when coadministered to healthy post-menopausal female subjects.


Inclusion Criteria: - Healthy post-menopausal female subjects, at least 45 years of age, with confirmed post-menopausal status - Hysterectomized subjects - Body Mass Index (BMI) less than or equal to 34.0 kg/m2 - Nonsmoker or smoker of fewer than 5 cigarettes per day as determined by history - An informed consent document signed and dated by the subject Exclusion Criteria: - History of significant blood, kidney, endocrine, lung, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic disease - Presence or history of deep vein thrombosis or transient ischemic attack - History of seizure disorder - Presence or history of glaucoma or increased intraocular pressure - Allergy to or unable to tolerate tamoxifen, desvenlafaxine, or venlafaxine - History of substance abuse within 1 year of study - A positive urine drug screen - Treatment with an investigational drug within 30 days - Consumption of grapefruit or grapefruit related citrus fruits - 12 lead ECG demonstrating QTc >450 msec at screening - Pregnant or nursing females - Use of prescription or nonprescription drugs and dietary supplements - History of sensitivity to heparin or heparin induced thrombocytopenia - Severe acute or chronic medical or psychiatric condition or laboratory abnormality - Use of CYP 2D6 inhibitors and CYP 3A4 inhibitors/inducers



Primary Contact:

Study Director
Pfizer CT.gov Call Center

Backup Contact:


Location Contact:

Miami, Florida 33126
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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