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Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy

This study has been completed.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
ASCEND Therapeutics
ClinicalTrials.gov Identifier:
NCT00160173
First received: September 8, 2005
Last updated: October 5, 2006
Last verified: October 2006
History of Changes
  Purpose

This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.


Condition Intervention Phase
Postmenopausal Symptoms
 Drug: Estradiol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy Study Comparing 0.9 g and 1.25 g EstroGel® 0.03% Doses With Placebo in the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Associated With Menopause

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by ASCEND Therapeutics:

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women 45-65 years
  • naturally or surgically postmenopausal
  • experiencing hot flushes

Exclusion Criteria:

  • hypersensitivity to estrogen replacement therapy
  • pregnancy or lactating
  • abnormal PAP smear
  • history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160173

  Show 109 Study Locations
Sponsors and Collaborators
ASCEND Therapeutics
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00160173     History of Changes
Other Study ID Numbers: S166.4.003
Study First Received: September 8, 2005
Last Updated: October 5, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by ASCEND Therapeutics:
Post menopausal vasomotor symptoms

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical
Estradiol
Estrogens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013