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

• ClinicalTrials.gov Identifier: NCT00195455
• Recruitment Status: Completed
• First Posted: September 19, 2005
• Last Update Posted: December 20, 2007
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by: Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 19, 2005
• Last Update Posted Date: December 20, 2007
• Study Start Date: February 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: September 13, 2005): To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 13, 2005)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.
• 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
• Brief Summary: The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous regimen 17 b estradiol/trimegestone combination.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Postmenopause

Intervention

• Drug: Trimegestone
• Drug: 17b Estradiol

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: September 13, 2005): 133
• Original Enrollment: Same as current
• Actual Study Completion Date: March 2007
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 45 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Mexico

Administrative Information

• NCT Number: NCT00195455
• Other Study ID Numbers: 0753T-101538
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Not Provided

Investigators

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

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: December 2007