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
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014