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

Phase 4

Completed

Conditions: Nocturnal Vasomotor Symptoms

Interventions: Drug: SCE-B
Drug: Placebo

Registration Number: NCT00592839

Lead Sponsor: Duramed Research

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 157

Inclusion Criteria

Naturally or surgically menopausal
Minimum 7 daily or 50 weekly moderate-to-severe hot flashes

Exclusion Criteria

Any contraindication to hormone therapy

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	0.3 mg SCE-B Daily
1	SCE-B	0.3 mg SCE-B Daily
2	SCE-B	0.625 mg SCE-B Daily
2	Placebo	0.625 mg SCE-B Daily
3	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes	Baseline to End of Treatment (Week 12)	Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort

Secondary Outcome Measures

Name	Time	Method
Mean Change in Individual Sleep Parameters on a Three-point Scale	Baseline to End of Treatment (Week 12)	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)
Mean Change in Stanford Sleepiness Scale	Baseline to End of Treatment (Week 12)	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).
Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).	From baseline to End of Treatment (Week 12)	Change= Week 12 biochemical markers of bone metabolism (N-telopeptide) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)	Baseline to End of Treatment (Week 12)	Change= Week 12 biochemical markers of bone metabolism (Osteocalcin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).	Baseline to End of Treatment (12 weeks)	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.