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Completed

NCT Number: NCT00367536

Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution

This study involves the experimental drug bazedoxifene acetate/conjugated estrogens (also called BZA/CE). This drug is not approved by the Food and Drug Administration (FDA).

About 24 subjects will take part in this study. Each subject's participation in this study will last for about 10 weeks. During this study, each subject will receive 3 different types of BZA/CE tablets plus an oral solution containing only BZA. The purpose of this study is to learn how the tablet dosage forms dissolve and are absorbed by the body compared to the BZA oral solution. In addition, information will also be learned about the safety and tolerability of these dosage forms given to healthy postmenopausal women.

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Key information

Conditions

Postmenopause

Age range

35 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Generally healthy, nonsmoking (or smoker of less than 10 cigarettes/day)
  • Postmenopausal women aged 35 to 70 years
  • At least 12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels at least 38 mIU/mL
  • Women 55 years of older must have at least 12 months of amenorrhea
  • Body mass index in the range of 18.0 to 35.0, with a minimum body weight of 50 kg

Exclusion criteria

  • A history or active presence of clinically important medical disease.
  • History or alcoholism or drug abuse within 1 year before study start.
  • Use of estrogen-, androgen-, or progestin-containing medication by a non-oral route of administration within 6 months before study day 1 must be approved by Wyeth Research

Treatment and study plan

bazedoxifene/conjugated estrogens combination tablet

Drug

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

An Open-label, Single-dose, Randomized-to-sequence, 4-period Crossover Bioavailability Study of Bazedoxifene Contained in Bazedoxifene/Conjugated Estrogen Tablets Administered to Healthy Postmenopausal Women.

Important dates

Study start
2006
Study completion
2006
First posted
Aug 23, 2006
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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