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

This study has been completed.

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

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
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:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 is now a wholly owned subsidiary of Pfizer:

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

Guadalajara, Jal., Mexico, 44340

Monterrey, N.l., Mexico, 64460

Monterrey, N.l., Mexico, 64000

Mexico City, Mexico, 01090

Mexico City, Mexico, 01030

Mexico City, Mexico, 02990

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:	Trial Manager	For Mexico, gomezlj@wyeth.com

More Information

No publications provided

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

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Postmenopause

Additional relevant MeSH terms:

Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on February 12, 2012