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

Purpose

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.

Condition	Intervention	Phase
Nocturnal Vasomotor Symptoms	Drug: SCE-B Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Drug Information available for: Estrogens, conjugated Estrogens, conjugated synthetic B

U.S. FDA Resources

Further study details as provided by Duramed Research:

Primary Outcome Measures:

Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes [ Time Frame: Baseline to End of Treatment (Week 12) ] [ Designated as safety issue: No ]
Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort

Secondary Outcome Measures:

Mean Change in Individual Sleep Parameters on a Three-point Scale [ Time Frame: Baseline to End of Treatment (Week 12) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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.

Enrollment:	157
Study Start Date:	December 2007
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 0.3 mg SCE-B Daily	Drug: SCE-B 0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo Other Names: Synthetic Conjugated Estrogens, B Enjuvia Drug: Placebo Matching placebo for 0.3 mg and 0.625 mg tablets
Experimental: 2 0.625 mg SCE-B Daily	Drug: SCE-B 0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo Other Names: Synthetic Conjugated Estrogens, B Enjuvia Drug: Placebo Matching placebo for 0.3 mg and 0.625 mg tablets
Placebo Comparator: 3 Placebo	Drug: Placebo Matching placebo for 0.3 mg and 0.625 mg tablets

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Any contraindication to hormone therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592839

Locations

United States, California
Duramed Investigational Site
Anaheim, California, United States, 92801
Duramed Investigational Site
Sacramento, California, United States, 95821
Duramed Investigational Site
San Diego, California, United States, 92108
United States, Florida
Duramed Investigational Site
Clearwater, Florida, United States, 33759
Duramed Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Kentucky
Duramed Investigational Site
Lexington, Kentucky, United States, 40509
Duramed Investigational Site
Louisville, Kentucky, United States, 40291
United States, Nebraska
Duramed Investigational Site
Lincoln, Nebraska, United States, 68510
United States, New Jersey
Duramed Investigational Site
Moorestown, New Jersey, United States, 08057
United States, New Mexico
Duramed Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, North Carolina
Duramed Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Duramed Investigational Site
Cleveland, Ohio, United States, 44122
Duramed Investigational Site
Mayfield Heights, Ohio, United States, 44124
United States, Oregon
Duramed Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Duramed Investigational Site
Pittsburgh, Pennsylvania, United States, 15206
United States, South Carolina
Duramed Investigational Site
Columbia, South Carolina, United States, 29201
United States, Texas
Duramed Investigational Site
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Duramed Research

Investigators

Study Chair:

Study Protocol Chair

Duramed Research, Inc.

More Information

No publications provided by Duramed Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Liu JH, Reape KZ, Hait HI. Synthetic conjugated estrogens-B and postmenopausal nocturnal vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):78-84.

Responsible Party:	Duramed Research, Inc., Duramed Research, Inc
ClinicalTrials.gov Identifier:	NCT00592839 History of Changes
Other Study ID Numbers:	DR-ENJ-401
Study First Received:	December 20, 2007
Results First Received:	February 4, 2010
Last Updated:	June 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

Nocturnal vasomotor symptoms in postmenopausal women

Additional relevant MeSH terms:

Estrogens, Conjugated (USP)
Estrogens
Estrogens, conjugated synthetic A
Estrogens, conjugated synthetic B

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013