Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Nocturnal Vasomotor Symptoms

Intervention / Treatment
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* Drug: SCE-B
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Naturally or surgically menopausal Minimum 7 daily or 50 weekly moderate-to-severe hot flashes Exclusion Criteria: Any contraindication to hormone therapy

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>0.3 mg SCE-B Daily | Drug: SCE-B<br>* 0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo<br>* Other names: Enjuvia;Drug: Placebo<br>* Matching placebo for 0.3 mg and 0.625 mg tablets<br>|
| Experimental: 2<br>0.625 mg SCE-B Daily | Drug: SCE-B<br>* 0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo<br>* Other names: Enjuvia;Drug: Placebo<br>* Matching placebo for 0.3 mg and 0.625 mg tablets<br>|
| Placebo Comparator: 3<br>Placebo | Drug: Placebo<br>* Matching placebo for 0.3 mg and 0.625 mg tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to End of Treatment (Week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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). | 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. | 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. | 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. | Baseline to End of Treatment (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nocturnal vasomotor symptoms in postmenopausal women