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Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00238732
First Posted: October 13, 2005
Last Update Posted: December 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.

Condition Intervention Phase
Vaginal Atrophy Drug: Bazedoxifene/Conjugated Estrogen Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: A Double-Blind, Randomized, Placebo-and Active-Controlled Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogens Combinations for Treatment of Moderate to Severe Vulvar/Vaginal Atrophy in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
  • Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.

Secondary Outcome Measures:
  • Vaginal pH at screening, and weeks 4 and 12.
  • Most bothersome moderate or severe vulvar/vaginal atrophy sympton at screening, and weeks 4 and 12.

Estimated Enrollment: 650
Study Start Date: October 2005
Study Completion Date: March 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Generally healthy, postmenopausal women, aged 40 to 65 years
  • Intact uterus
  • At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome

Exclusion Criteria:

  • Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia
  • Thrombophlebitis, thrombosis or thromboembolic disorders
  • Neuro-ocular disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238732


  Show 63 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

ClinicalTrials.gov Identifier: NCT00238732     History of Changes
Other Study ID Numbers: 3115A1-306
First Submitted: October 12, 2005
First Posted: October 13, 2005
Last Update Posted: December 28, 2007
Last Verified: December 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Vaginal Atrophy
Postmenopause

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical
Estrogens
Estrogens, Conjugated (USP)
Bazedoxifene
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Bone Density Conservation Agents