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Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00472004
First Posted: May 10, 2007
Last Update Posted: October 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
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: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle) Drug: Tibolone (Livial) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open Label Study To Compare The Efficacy, Safety And Tolerability Of 17-B Estradiol/Trimegestone CC 1 Mg (Totelle) And Tibolone (Livial) In Postmenopausal Women.

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Decreased of Vasomotor Symptoms [from baseline to six and twelve months] [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Changes in Body Weight (from baseline to six and twelve months) [ Time Frame: 1 year ]
  • Quality of Life (from baseline to six and twelve months) [ Time Frame: 1 year ]
  • Treatment Adherence (from baseline to six and twelve months) [ Time Frame: 1 year ]
  • Breast Tenderness (from baseline to six and twelve months) [ Time Frame: 1 year ]

Enrollment: 204
Study Start Date: February 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
17B Estradiol (1mg) / (0.125 mg) Trimegestone (TMG) Continuous combined, 1 Daily, 1 year duration
Drug: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)
17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration
Other Name: Totelle
Active Comparator: 2
Tibolone 2.5 mg 1 daily, 1 year duration
Drug: Tibolone (Livial)
Tibolone 2.5 mg 1 daily, 1 year duration
Other Name: Livial

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472004


Locations
Mexico
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 01090
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00472004     History of Changes
Other Study ID Numbers: 0753T-101800
B2481004
First Submitted: May 8, 2007
First Posted: May 10, 2007
Last Update Posted: October 29, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Tibolone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Androgen Antagonists
Hormone Antagonists
Antihypertensive Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Modulators
Anabolic Agents