Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Women

NCT00706225 | Completed Phase 1

• 1 other identifier: 3115A1-1134
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA) which is being studied for possible prevention and treatment of postmenopausal osteoporosis. PREMARIN® (conjugated estrogens \[CE\]) is approved by FDA to treat moderate to severe symptoms of menopause (i.e., hot flashes, and/or vulvar and vaginal atrophy) and for the prevention of postmenopausal osteoporosis. The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of PREMARIN® when administered together with multiple doses of bazedoxifene (BZA) to healthy postmenopausal women. Information will also be obtained regarding the safety and tolerability of the study medications when given together to healthy postmenopausal women.

Conditions

Postmenopause

Outcome Measures

Primary Outcomes (1)

• To evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of bazedoxifene (BZA) and a single dose of conjugated estrogens (CE) when co administered to healthy postmenopausal women.

  3 months

Secondary Outcomes (1)

• To assess the safety of conjugated estrogens (CE) and bazedoxifene (BZA) when co administered to healthy postmenopausal women.

  3 months

Study Arms (1)

1

EXPERIMENTAL

Bazedoxifene and Conjugated Estrogens (BZA \& CE)

Drug: Bazedoxifene and conjugated estrogens

Interventions

Bazedoxifene and conjugated estrogens DRUG

Bazedoxifene 20 mg tablet once daily for 7 days. Conjugated Estrogens 0.625 mg tablet, single doses one week apart.

1

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, postmenopausal woman, (either naturally or surgically and have blood hormone levels consistent with a postmenopausal state for specified subjects) between the ages of 35 and 70 years, inclusive
• Have not participated in a clinical drug study for at least 30 days prior to study medication administration,
• Must not have a history of drug or alcohol abuse within 1 year and do not 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)
• Must either be a non-smoker or smoke less than 10 cigarettes per day, and must be able to abstain from smoking during clinic confinements,
• Must not donate any other plasma or blood during the total study.
• All test results and study criteria for the study are met.

You may not qualify if:

• Only healthy postmenopausal women are eligible.
• Health assessed by clinical chemistry laboratory results and physical exam.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Unknown Facility

Daytona Beach, Florida, 32117, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

bazedoxifene; Estrogens, Conjugated (USP)

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 27, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: September 23, 2010

Record last verified: 2010-09

Locations

US (1)