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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00238732
First received: October 12, 2005
Last updated: December 19, 2007
Last verified: December 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   40 Years to 65 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00238732     History of Changes
Other Study ID Numbers: 3115A1-306
Study First Received: October 12, 2005
Last Updated: December 19, 2007
Health Authority: United States: Food and Drug Administration
Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on August 27, 2014