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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
157
0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo
Matching placebo for 0.3 mg and 0.625 mg tablets
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
...and 7 more locations
Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes
Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort
Time frame: Baseline to End of Treatment (Week 12)
Mean Change in Individual Sleep Parameters on a Three-point Scale
Change= Week 12 weekly average sleep quality score - Baseline weekly average sleep quality score for the intent-to-treat cohort. The sleep quality was derived from the subject self-assessment of sleep quality graded on a three-point scale (3=excellent, 2=good, 1=poor sleep quality)
Time frame: Baseline to End of Treatment (Week 12)
Mean Change in Stanford Sleepiness Scale
Change= Week 12 score - Baseline Score. Daytime sleepiness was derived from the subject self-assessment how they felt at a particular time of day. Subjects rated daytime sleepiness on the 7 point Stanford Sleepiness Scale (1=most alert to 7=sleepiest).
Time frame: Baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).
Change= Week 12 biochemical markers of bone metabolism (N-telopeptide) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
Time frame: From baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)
Change= Week 12 biochemical markers of bone metabolism (Osteocalcin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
Time frame: Baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).
Change= Week 12 biochemical markers of bone metabolism (Sex Hormone Binding Globulin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
Time frame: Baseline to End of Treatment (12 weeks)
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