Study Comparing 17B Estradiol/TMG CC 1mg vs. Tibolone in Postmenopausal Women
Information source: Wyeth
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vasomotor Symptoms
Intervention: Intervention 1 Arm 1: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Drug); Tibolone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com
Summary
This is a Phase IV prospective, randomized, open label, comparative, multicenter study in
generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and
Livial (Tibolone).
Clinical Details
Official title: A Prospective, Randomised, Open Label Study to Compare the Efficacy, Safety and Tolerability of 17B Estradiol/TMG CC 1mg and Tibolone in Postmenopausal Women
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Evaluate the efficacy of Totelle and Tibolone in controlling the vasomotor symptoms and cycle control
Secondary outcome: Evaluate the effects of Totelle and Tibolone on tolerability profile defined as: weight changes, breast tenderness; Quality of Life and Adherence to Treatment
Eligibility
Minimum age: 45 Years.
Maximum age: 55 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria
- Generally healthy postmenopausal women
- Last natural (without exogenous hormone therapy) menstrual cycle completed at least 12
consecutive months prior to screening and without any other kind of gynecological
bleeding during this same period
- At least 1 year of natural occurring amenorrhea
Exclusion Criteria
- Known or suspected estrogen-dependent neoplasia
- Endometrial hyperplasia
- Any malignancy with the exception of a history of basal cell carcinoma of the skin
Locations and Contacts
Trial Manager, Email: clintrialparticipation@wyeth.com
Puebla 72410, Mexico; Recruiting
Mexico, DF 6700, Mexico; Recruiting
Mexico, DF 53100, Mexico; Recruiting
Mexico, DF 11000, Mexico; Recruiting
Mexico, DF 11800, Mexico; Not yet recruiting
Monterrey, Nuevo Leon 64060, Mexico; Recruiting
Additional Information
Starting date: February 2006
Ending date: December 2008
Last updated: December 21, 2007
|
