Not Signed In -
Estradiol Injection |
Delestrogen; Depo-Estradiol; Estra-L; Gynogen; Valergen |
Clinical Trial: Multi-Center Study to Evaluate Estradiol Transdermal Spray in the Treatment of Symptomatic Postmenopausal Women
This study is currently recruiting patients.
|
Purpose
Estradiol treatment is effective at reducing vasomotor symptoms (eg, hot flushes) in postmenopausal women. Vivus has a proprietary spray delivery system (Evamist) for estradiol. This study will evaluate the safety and efficacy of this product.
| Condition | Intervention | Phase |
|---|---|---|
| Postmenopause Hot Flashes | Drug: Topical estradiol | Phase III |
MedlinePlus related topics: Menopause
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Estradiol Metered-Dose Transdermal Spray (MDTS) in the Treatment of Vasomotor Symptoms in Postmenopausal Women
Further Study Details:
Primary Outcomes: Incidence and severity of hot flushes; Safety
Expected Total Enrollment: 450
Expected Total Enrollment: 450
Study start: December 2004
This is a multicenter, randomized, double-blind, placebo-controlled trial evaluating different doses of transdermal estradiol delivered by spray to symptomatic postmenopausal women. The endpoints are the reduction in frequency and severity of hot flushes.
Eligibility
Ages Eligible for Study: 35 Years and above, Genders Eligible for Study: Female
Criteria
Inclusion Criteria: -Postmenopausal women -Age 35 or older -Frequent moderate to severe hot flushes -Qualifying general medical health
Exclusion Criteria: -Disqualifying gynecological disorders -Disqualifying dermatological disorders -Disqualifying concurrent conditions
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00122200
Vivus www.spraystudy.com
Virginia
University of Eastern Virginia, Norfolk, Virginia, 23507, United States; Recruiting
Barbara Ross 757-446-8929
Study chairs or principal investigators
Sam Teichman, MD, Study Director, Vivus Clinical Research Department
More Information
Study ID Numbers: EST-01
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 21, 2005
ClinicalTrials.gov Identifier: NCT00122200
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 21, 2005
ClinicalTrials.gov Identifier: NCT00122200
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26
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