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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00472004 |
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).
Condition | Intervention | Phase |
---|---|---|
Vasomotor Symptoms |
Drug: Intervention 1 Arm 1: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined Drug: Tibolone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 200 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration
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Drug: Intervention 1 Arm 1: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined
17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration
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2: Active Comparator
Tibolone 2.5 mg 1 daily, 1 year duration
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Drug: Tibolone
Tibolone 2.5 mg 1 daily, 1 year duration
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Ages Eligible for Study: | 45 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
Contact: Trial Manager | clintrialparticipation@wyeth.com |
Mexico | |
Recruiting | |
Puebla, Mexico, 72410 | |
Mexico, DF | |
Recruiting | |
Mexico, DF, Mexico, 6700 | |
Recruiting | |
Mexico, DF, Mexico, 53100 | |
Recruiting | |
Mexico, DF, Mexico, 11000 | |
Not yet recruiting | |
Mexico, DF, Mexico, 11800 | |
Mexico, Nuevo Leon | |
Recruiting | |
Monterrey, Nuevo Leon, Mexico, 64060 |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 0753T-101800 |
Study First Received: | May 8, 2007 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00472004 |
Health Authority: | Mexico: Federal Commission for Protection Against Health Risks |
Tibolone Benzoates Estradiol 3-benzoate Estradiol valerate |
Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol |
Estrogens Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Reproductive Control Agents |
Cardiovascular Agents Antihypertensive Agents Hormones Pharmacologic Actions Estrogen Receptor Modulators Anabolic Agents Androgen Antagonists Therapeutic Uses |