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OpenTrials
Completed

NCT Number: NCT00195455

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

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

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Key information

Conditions

Postmenopause

Age range

45 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Guadalajara, Jalisco, Mexico

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trimegestone

Drug

17b Estradiol

Drug

Primary outcomes

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

Secondary outcomes

  1. Study bleeding patterns throughout the treatment period (6 months)

  2. Evaluate changes in the Menopause-Specific Quality of Life Questionnaire

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Dec 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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