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

This study has been completed.

First Received: September 12, 2005 Last Updated: December 17, 2007 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00195455

Purpose

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

Condition	Intervention	Phase
Postmenopause	Drug: Trimegestone Drug: 17b Estradiol	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Prospective Open Label Study to Evaluate Vasomotor Symptoms Control and Bleeding Patterns With a Continuous Regimen of a New Progestin Trimegestone 0.125 mg and 17 b Estradiol 1 mg (Totelle),as HT on Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Menopause

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen RU 27987 Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.

Secondary Outcome Measures:

Study bleeding patterns throughout the treatment period (6 months)
Evaluate changes in the Menopause-Specific Quality of Life Questionnaire

Estimated Enrollment:	133
Study Start Date:	February 2005
Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	45 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195455

Locations

Mexico

Mexico City, Mexico, 01030

Mexico City, Mexico, 01090

Mexico City, Mexico, 02990
Mexico, Jal.

Guadalajara, Jal., Mexico, 44340
Mexico, N.L.

Monterrey, N.L., Mexico, 64000

Monterrey, N.L., Mexico, 64460

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Mexico, gomezlj@wyeth.com

More Information

No publications provided

Study ID Numbers:	0753T-101538
Study First Received:	September 12, 2005
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00195455 History of Changes
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Wyeth:

Postmenopause

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Estradiol 17 beta-cypionate

Reproductive Control Agents
Hormones
Estradiol
Pharmacologic Actions
Estradiol 3-benzoate
Therapeutic Uses
Polyestradiol phosphate

ClinicalTrials.gov processed this record on February 08, 2010