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Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.

NCT ID: NCT00195455

Last Updated: 2007-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-03-31

Brief Summary

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The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous regimen 17 b estradiol/trimegestone combination.

Detailed Description

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Conditions

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Postmenopause

Keywords

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Postmenopause

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Trimegestone

Intervention Type DRUG

17b Estradiol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Generally healthy postmenopausal women 45 to 55 years of age inclusive, with at least 1 year of natural occurring amenorrhea, with vasomotor symptoms, with at least 4 hot flushes per day
* Intact uterus

Exclusion Criteria

* Known or suspected breast carcinoma or estrogen-dependent neoplasm
* Undiagnosed abnormal genital bleeding
Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Mexico, [email protected]

Locations

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Guadalajara, Jalisco, Mexico

Site Status

Monterrey, N.L., Mexico

Site Status

Monterrey, N.L., Mexico

Site Status

Mexico City, , Mexico

Site Status

Mexico City, , Mexico

Site Status

Mexico City, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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0753T-101538

Identifier Type: -

Identifier Source: org_study_id