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A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of SCE-B on Nocturnal Vasomotor Symptoms in Postmenopausal Women
This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a pap smear. Participants will be asked to wear a monitoring device for a portion of the study and be asked to complete a daily dairy.
Age
30 - 65 years
Sex
FEMALE
Healthy Volunteers
Yes
Duramed Investigational Site
Anaheim, California, United States
Duramed Investigational Site
Sacramento, California, United States
Duramed Investigational Site
San Diego, California, United States
Duramed Investigational Site
Clearwater, Florida, United States
Duramed Investigational Site
West Palm Beach, Florida, United States
Duramed Investigational Site
Lexington, Kentucky, United States
Duramed Investigational Site
Louisville, Kentucky, United States
Duramed Investigational Site
Lincoln, Nebraska, United States
Duramed Investigational Site
Moorestown, New Jersey, United States
Duramed Investigational Site
Albuquerque, New Mexico, United States
Start Date
December 1, 2007
Primary Completion Date
February 1, 2009
Completion Date
February 1, 2009
Last Updated
July 19, 2013
157
ACTUAL participants
SCE-B
DRUG
Placebo
DRUG
Lead Sponsor
Duramed Research
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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