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OpenTrials
Completed

NCT Number: NCT00396799

Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women

The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated estrogens tablets produced using a new manufacturing process

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Key information

Conditions

Menopause

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

  • Healthy, postmenopausal women aged 35 to 70 years and weighing at least 50 kg (approx. 110 lbs).
  • At least 6 months of spontaneous amenorrhea (with follicle-stimulating hormone levels of 39 mIU/mL or greater).
  • Nonsmoker or smoker of fewer than 10 cigarettes per day, with ability to abstain for 5 days.

Exclusion criteria

  • Women with amenorrhea starting after 54 years of age.
  • A history or active presence of clinically important medical diseases.
  • Use of oral estrogen-, progestin, androgen-, or SERM-containing drug products within 30 days before receiving study drug.

Treatment and study plan

bazedoxifene/conjugated estrogens

Drug

Primary outcomes

  1. Pharmacokinetic measures of blood levels of endogenous estrogen hormones, conjugated estrogens and bazedoxifene.

Secondary outcomes

  1. Safety will be evaluated from reported signs and symptoms, scheduled physical examinations, gynecologic examinations, vital sign measurements, 12-lead ECG and clinical laboratory test results.

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, 2-Period, Crossover, Pivotal Bioequivalence Study Between Bazedoxifene Acetate/Conjugated Estrogens (Premarin Current Process) and Bazedoxifene Acetate/Conjugated Estrogens (Premarin New Process) Tablets Administered to Healthy Postmenopausal Women

Important dates

Study start
2006
Study completion
2006
First posted
Nov 8, 2006
Registry last updated
Mar 13, 2007

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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