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 (Responsible Party):
ASCEND Therapeutics
ClinicalTrials.gov Identifier:
NCT00160173
First received: September 8, 2005
Last updated: July 11, 2013
Last verified: July 2013
  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:


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
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: 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

Responsible Party: ASCEND Therapeutics
ClinicalTrials.gov Identifier: NCT00160173     History of Changes
Other Study ID Numbers: S166.4.003
Study First Received: September 8, 2005
Last Updated: July 11, 2013
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 July 29, 2014