Status:
COMPLETED
Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy
Lead Sponsor:
ASCEND Therapeutics
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Postmenopausal Symptoms
Eligibility:
FEMALE
45-65 years
Phase:
PHASE4
Brief Summary
This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.
Detailed Description
The primary objective of this study was to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause by comparing the efficacy of 0.9 g and 1.2...
Eligibility Criteria
Inclusion
- Women 45-65 years
- naturally or surgically postmenopausal
- experiencing hot flushes
Exclusion
- hypersensitivity to estrogen replacement therapy
- pregnancy or lactating
- abnormal PAP smear
- history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy
Key Trial Info
Start Date :
December 2 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2005
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT00160173
Start Date
December 2 2004
End Date
September 6 2005
Last Update
September 13 2022
Active Locations (109)
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Tucson, Arizona, United States