NCT00727129CompletedPhase 3
Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, to Demonstrate the Efficacy of 12 Weeks of Treatment With USL-221 on Moderate to Severe Vasomotor Symptoms and Vulvar/Vaginal Atrophy in Postmenopausal Patients
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Upsher-Smith Laboratories
- Enrollment
- 495
- Primary Endpoint
- Daily frequency and severity of moderate to severe vasomotor symptoms
Study Overview
Brief Summary
The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Postmenopausal women
- •Have moderate to severe hot flashes
- •Normal Pap Smear
Exclusion Criteria
- •Abnormal mammogram
- •Abnormal clinical breast exam
Outcomes
Primary Outcomes
Daily frequency and severity of moderate to severe vasomotor symptoms
Secondary Outcomes
- vulvar and vaginal atrophy
Investigators
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