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

NCT ID: NCT00592839

Last Updated: 2013-07-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-02-28

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.

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Detailed Description

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Conditions

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Nocturnal Vasomotor Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

0.3 mg SCE-B Daily

Group Type EXPERIMENTAL

SCE-B

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Matching placebo for 0.3 mg and 0.625 mg tablets

2

0.625 mg SCE-B Daily

Group Type EXPERIMENTAL

SCE-B

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Matching placebo for 0.3 mg and 0.625 mg tablets

3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo for 0.3 mg and 0.625 mg tablets

Interventions

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SCE-B

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

Intervention Type DRUG

Placebo

Matching placebo for 0.3 mg and 0.625 mg tablets

Intervention Type DRUG

Other Intervention Names

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Synthetic Conjugated Estrogens, B Enjuvia

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Duramed Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Protocol Chair

Role: STUDY_CHAIR

Duramed Research, Inc.

Locations

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Duramed Investigational Site

Anaheim, California, United States

Site Status

Duramed Investigational Site

Sacramento, California, United States

Site Status

Duramed Investigational Site

San Diego, California, United States

Site Status

Duramed Investigational Site

Clearwater, Florida, United States

Site Status

Duramed Investigational Site

West Palm Beach, Florida, United States

Site Status

Duramed Investigational Site

Lexington, Kentucky, United States

Site Status

Duramed Investigational Site

Louisville, Kentucky, United States

Site Status

Duramed Investigational Site

Lincoln, Nebraska, United States

Site Status

Duramed Investigational Site

Moorestown, New Jersey, United States

Site Status

Duramed Investigational Site

Albuquerque, New Mexico, United States

Site Status

Duramed Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Duramed Investigational Site

Cleveland, Ohio, United States

Site Status

Duramed Investigational Site

Mayfield Heights, Ohio, United States

Site Status

Duramed Investigational Site

Medford, Oregon, United States

Site Status

Duramed Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Duramed Investigational Site

Columbia, South Carolina, United States

Site Status

Duramed Investigational Site

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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. doi: 10.1097/AOG.0b013e31823c0145.

Reference Type DERIVED
PMID: 22183214 (View on PubMed)

Other Identifiers

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DR-ENJ-401

Identifier Type: -

Identifier Source: org_study_id

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