Study to Evaluate the Effects of SCE-B on Nocturnal Vasomotor Symptoms in Postmenopausal Women - Full Text View

Sponsor:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00592839

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: Enjuvia Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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 hot flashes [ Time Frame: Weekly and from Screening to End of Treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change in individual sleep patterns [ Time Frame: Weekly and from Screening to End of Treatment ] [ Designated as safety issue: No ]
Mean change in Stanford Sleepiness Scale Scores [ Time Frame: Each study visit and from Screening to End of Treatment ] [ Designated as safety issue: No ]
Mean change in average frequency of awakenings due to hot flashes [ Time Frame: Monthly and from Screening to End of Treatment based on monitoring device data ] [ Designated as safety issue: No ]
Mean change in bone markers and SHBG [ Time Frame: From baseline to End of Treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
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
1: Experimental	Drug: Enjuvia 0.3mg or 0.625mg tablets daily plus matching placebo
2: Experimental	Drug: Enjuvia 0.3mg or 0.625mg tablets daily plus matching placebo
3: Placebo Comparator	Drug: Placebo Matching placebo for 0.3mg and 0.625mg 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
San Diego, California, United States, 92108
Duramed Investigational Site
Sacramento, California, United States, 95821
Duramed Investigational Site
Anaheim, California, United States, 92801
United States, Florida
Duramed Investigational Site
West Palm Beach, Florida, United States, 33409
Duramed Investigational Site
Clearwater, Florida, United States, 33759
Duramed Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Kentucky
Duramed Investigational Site
Louisville, Kentucky, United States, 40291
Duramed Investigational Site
Lexington, Kentucky, United States, 40509
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
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

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

Keywords provided by Duramed Research:

Nocturnal vasomotor symptoms in postmenopausal women

Additional relevant MeSH terms:

Estrogens
Estrogens, Conjugated (USP)
Estrogens, conjugated synthetic B
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010