Completed

NCT Number: NCT00592839

Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (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.

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Key information

Conditions

Nocturnal Vasomotor Symptoms

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Duramed Investigational Site, Anaheim, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Any contraindication to hormone therapy

Treatment and study plan

SCE-B

Drug

0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo

Other names: Synthetic Conjugated Estrogens, B, Enjuvia

Placebo

Drug

Matching placebo for 0.3 mg and 0.625 mg tablets

Primary outcomes

Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes

Time frame: 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 outcomes

Mean Change in Individual Sleep Parameters on a Three-point Scale

Time frame: 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

Time frame: 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).

Time frame: 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)

Time frame: 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).

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study title

A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of SCE-B on Nocturnal Vasomotor Symptoms in Postmenopausal Women

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jan 14, 2008
Registry last updated: Jul 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.