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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00472004
First received: May 8, 2007
Last updated: October 28, 2010
Last verified: October 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   45 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00472004     History of Changes
Other Study ID Numbers: 0753T-101800, B2481004
Study First Received: May 8, 2007
Last Updated: October 28, 2010
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

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

ClinicalTrials.gov processed this record on May 19, 2013