Study Evaluating Premarin and Bazedoxifene Potential Interaction

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00745173
• Date of registration: 02/09/2008
• Prospective Registration: No
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Study Evaluating Premarin and Bazedoxifene Potential Interaction
• Scientific title: An Open-Label, Single/Multiple Dose Non-Randomized, 3-Period, Crossover Study To Determine The Potential Drug Interaction Of Conjugated Estrogens (CE) On Bazedoxifene In Healthy Postmenopausal Women.
• Date of first enrolment: September 2008
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00745173
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Medical Monitor
• Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- For inclusion into the study, women must be healthy and postmenopausal (either
naturally or surgically) between the ages of 35 and 70, inclusive.

- Blood hormone levels must be consistent with a postmenopausal state (for specified
subjects).

- They can either be a non-smoker or smoke less than 10 cigarettes per day, and be able
to abstain from smoking during clinic confinements

Exclusion Criteria:

- A subject will be excluded from participation if they :

- Have participated in a clinical drug study within 30 days prior to study medication
administration;

- Have a history of drug or alcohol abuse within 1 year or consume more than 2 standard
units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of
80-proof alcohol or 6 ounces of wine);

- Donate any other plasma or blood during the total study.



Age minimum: 35 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Postmenopause

Intervention(s)

Drug: Premarin

Primary Outcome(s)

Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters [Time Frame: 3 months]

Secondary Outcome(s)

To continue assessment of the safety profile as well as the tolerability the two drugs administered in combination in this population. [Time Frame: 3 months]

Secondary ID(s)

3115A1-1135

Source(s) of Monetary Support

Please refer to primary and secondary sponsors